Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
On the affected ct systems and software versions, varian rpm drive is not mapped in ct user profile after logout/login. the map drive utility maps the varian drive using full varian credentials in the service login and then creates a script that maps it with full varian credentials in the ct user login. once the script has run in the ct login and the user acknowledges the drive mapped successfully, the script deletes itself. on subsequent logins, the drive will not connect because the varian credentials are no longer available. should this situation occur, the user will be unable to perform pulmonary gated scans.
Acción
Philips is advising users to contact Service to login to service mode to reconnect Varian RPM drive. Philips is implementing a software upgrade as a permanent correction. This action has been closed out on 15 June 2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
A firmware anomaly inside the detector (4343rc) can cause the detector to appear ready for acquisition on very short time intervals while it actual fact it is not ready, resulting in incorrectly acquired x-ray images.If a corrupted image cannot be used for its clinical purpose, it may be necessary to retake the image, leading to additional exposure for the patient.
Acción
Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact the affected customers when the Field Action Kit is available to be implemented. This action has been closed-out on 16/05/2017
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ge healthcare has become aware of a potential safety issue in the revolution ct patient table that can result in unintended motion in cases involving large patients. the revolution ct cradle can descend on its own after activation by the user. this can put the patient at risk for harm. the harm can involve the impinging or crushing of a hand if caught between the cradle and ct inner gantry bore. no injuries have been reported to date related to this issue.
Acción
GE Healthcare is advising users to continue to use the Revolution CT system, and ensure the warnings regarding Patient Positioning in the IFU are followed. GE will be correcting all affected systems. This action has been closed-out on 20/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
In february 2016, medtronic issued a medical device hazard alert communication that indicated medtronic reveal linq insertable cardiac monitors (icms) could experience a performance issue that affects the recommended replacement time (rrt) alert. this original communication named phase 1, also explained that medtronic was awaiting a software update to address this issue.Medtronic has now developed the necessary software and is ready to begin applying this update to all reveal linq icms which constitutes phase 2 of the alert.Once installed, this software update will reset rrt & end of service (eos) status and re-enable wireless transmissions for devices that have experienced premature rrt /eos. the update will also prevent the occurrence of premature rrt alerts due to this issue. refer to the original communication for additional details (rc-2016-rn-00202-1).
Acción
Medtronic will be providing a software update as a permanent correction. For more information, please see https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor. This action has been closed-out on 17/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
A firmware anomaly inside the detector (px4343rg) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not ready. this may result in an inadequate acquisition of the x-ray image. if a corrupted image cannot be used for its clinical purpose, it may be necessary to retake with additional exposure.
Acción
Philips is implementing a software upgrade to version 3.0.6 as a permanent correction. This action has been closed-out on 12/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There have been some reported cases where the flow diverter used in these products is being cracked. the flow diverter is the blue adaptor that attaches to the patient valve. the flow diverter directs the patient’s exhaled breath to atmosphere or into a peep (positive end expiratory pressure)valve where a peep valve is being used. a cracked flow diverter can affect the peep valves ability to hold peep. as the flow diverter is on the expiratory side of the breathing system there is no effect on the resuscitators ability to deliver gas to the patient. additionally, in the event of a cracked flow diverter, there are two discrete one way valves isolating the expiratory side from the inspiratory side. thus there is no pathway by which any foreign material could enter the inspiratory side of the resuscitator. a cracked flow diverter has no affect upon the resuscitators ability to deliver gas to the patient.
Acción
Schell Medical is advising users to inspect stocks for the affected lot numbers. If any of the impacted products show signs of cracking, quarantine for return and replacement by Schell as per normal procedures. This action has been closed-out on 03/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medline have received reports that due to a potential defective component on the circuit board, the clipper charger can overheat. this could result in a clipper charger malfunction and may cause thermal injuries to the user.
Acción
Medline are advising users to discard the affected chargers. Medline will replace all affected chargers, and is advising users to use an alternative method of hair removal until a replacement arrives. This action has been closed-out on 03/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer has become aware of the potential of an inability to obtain a valid calibration when using vitros afp reagent packs.Ortho clinical diagnostics (ortho) confirmed that the affected lots exhibited an increase in reaction signal over time. the investigation indicates that there is the potential for sample concentrations to increase during the 28-day calibration timeframe by up to 12% and that the magnitude of the positive bias will decrease as sample concentrations increase. there have been no reports of injuries as a result of this issue.
Acción
Ortho Clinical is advising users to discontinue use and discard affected lots. If users are able to successfully calibrate and QC results are acceptable, users may continue to use the affected lots until the replacement stock arrives.
Previously reported results are valid, providing that QC results were within acceptable limits. This action has been closed out on 13 Jun 2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
When dicom is exporting a 3d monaco plan and the “composite field sequencing” (cfs) checkbox is selected, the y jaws will snap to the port shape when they should remain where they were defined. this occurs when the port shape used to define or edit the mlc positions extends beyond or inside the actual jaw positions. the defect is triggered when using a workflow for forward planning imrt that involves creating multiple beams for the same gantry angle with a single mlc shape defined for each beam. these beams are then exported using cfs to combine the individual 3d beams into a single imrt beam sequence. the planned and approved dose distribution will not agree with the dose delivered. this deviation is considered as a geometric miss and the patient can be overdosed or under dosed depending on whether the mlc shape is drawn outside or inside of the collimator jaws. there is a remote probability that serious injury could occur.
Acción
Elekta is advising users to avoid using the CFS option for any 3D delivery mode plan, including Forward IMRT based plans. A software correction will be implemented as a permanent correction. This action has been closed-out on 09/05/2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. there have been no injuries reported as a result of this issue. at this site, a magnet heater probe connection became disconnected. this resulted in ice build-up within the magnet blocking the cryogen vent. since the vent was blocked by ice, the later magnet quench caused gas to be vented into the magnet room.
Acción
GE Healthcare is advising users to notify GE Service Engineer if the Magnet Monitoring Unit (MMU) detects any abnormal or out of specification reading. If the Magnet Monitoring Unit (MMU) detects an error it will display a pop-up window on the system monitor which will be seen by the operator. MMU reported errors will be in the form of a CAS7XX error (XX being the specific error) with a brief description.
If no Magnet Monitoring Unit errors are reported, there are no action is required. Users can continue normal use of the affected products.
GE will be correcting all affected units. This action has been closed out on 13 Jun 2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The thermogard dual dispersive electrode pads are not compatible with some brands of electrosurgical generators using “passive” cqm (contact quality monitoring) systems. whilst there have been no reports of injury or death, there is a possibility of a patient burn when used with a “passive” cqm electrosurgical generator.
Acción
ConMed Linvatec is advising users to inspect stock and discontinue use of affected devices. Product can be returned to ConMed for credit. This action has been closed-out on 03/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An issue has been identified where size 5 laryngeal tubes have been inadvertently packaged in size 4 laryngeal tube set packs. the tubes within the pack are correctly labelled as size 5 and this information is visible through the packaging.
Acción
Users are asked to quarantine and discontinue use of the affected item code and lot listed in the customer letter and to follow the instructions given when returning the goods. If your facility has distributed the affected products to other persons or facilities, customers are also asked to promptly forward a copy of the recall letter to those recipients. This action has been closed-out on 22/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker has discovered that the specialty 33mm cutter outer diameter was designed too large and would thus prevent the device from passing through the specialty clamping barrel. this may result in the surgery time being extended by up to 15 minutes to retrieve and use an alternative readily available instrument.
Acción
Stryker is advising customers to inspect stocks and quarantine any affected units prior to their return to Stryker. This action has been closed-out on 03/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Zimmer inc. has become aware of specific lots of sterile hip and trauma implant screws manufactured between february 2016 and march 2016. these screws are packaged with a double barrier system, two plastic trays and two tyvek lids, to provide sterile integrity. process monitoring conducted as part of the standard packaging process identified that in some instances, a small hole may be present in the inner tray, which were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. the outer tray is not affected and the device’s sterile integrity remains until the outer tray is opened.
Acción
Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. Patient follow up is at the discretion of the treating surgeon. This action has been closed-out on 27/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An issue has been detected with the foil pouches of specific lots of sterile trabecular metal implants that were manufactured between april 2011 and october 2012. retrospective testing performed by zimmer biomet as a result of an internal review of the packaging system revealed that in some instances, tears/holes in some of the foil pouches were present in either the inner foil pouch or the outer foil pouch, but never both in the same sample. no product complaints have been reported for this issue. the affected product was distributed between april 2011 and march 2016.In a worst case scenario, if an issue with the foil pouch is detected during surgery, this will result in a slight delay to obtain another implant. if there is an issue with the foil pouch that goes undetected and also has resulted in a loss of sterility, a peri-prosthetic infection may occur. the risk associated with a peri-prosthetic infection is a revision or potential multi-stage revision to treat the infection.
Acción
Peri-prosthetic infections associated with the device/surgical site are most likely to manifest within 12 months of the device being implanted. Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. This action has been closed-out on 27/01/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has received complaints of positive shift of patient and qc results when the alti assay is calibrated with the affected dimension enzyme ii calibrator lots. internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. there is no risk to patients however there may be a delay in results.
Acción
Siemens has reassigned the bottle values of all Enzyme II calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided.
A review of previously generated results due to this issue is at the discretion of the laboratory.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has received complaints of positive shift of patient and qc results when the alti assay is calibrated with certain dimension vista enzyme 2 calibrator lots. internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. there is no risk to patients however there may be a delay in reporting patient results.
Acción
Siemens has reassigned the bottle values of all Enzyme 2 calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided.
A review of previously generated results due to this issue is at the discretion of the laboratory.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics is issuing an urgent recall for product correction notice for the hettich centrifuge buckets (model 4464-r) of affected hettich rotanta 46 rsc robotic and rotanta 460 robotic centrifuges. hettich, the centrifuge manufacturer is currently investigating the reason for premature bucket failures. there is the possibility that material changes may have an impact of the strength of the buckets. when the hettich centrifuge bucket fails during centrifugation, the potential exists for a delay in patient testing and the potential for movement/rotation of the centrifuge.
Acción
Siemens is providing users with instructions to conduct a weekly check of centrifuge buckets for signs of cracking and replace if required. Additionally, the maximum RPM should be reduced to 3,500 rpm.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips healthcare became aware of certain issues with the affected products through testing & customer feedback. the identified issues include;- imr cardiac - irregular appearance of contrast in vessels;- missing image annotations in cct- halo artefacts- incorrect z annotation on plan box for coronal/sagittal surviews- post injection delay between timed scans may be inaccurate- unintended change of acquisition timing on scan ruler- bolus tracker does not trigger as expected- cardiac step & shoot stops after arrhythmia detected- tracker scan halted with fdom- error when auto roi placement outside patient anatomy- no "go" when hr outside acceptable range- unplanned results during multi-phase pulmo series, may cause a system crash- dynamic myocardial perfusion acquisition halted after 1st shot- double clicking ecg phase bar crashes exam application- incorrect phase tolerance for cardiac s&s; &- ring artefacts on high resolution images, idose4 & imr.
Acción
Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips healthcare became aware of certain issues with the affected products through testing and customer feedback. the identified issues include;- imr cardiac - irregular appearance of contrast in vessels; -missing image annotation’s in cct;- halo artefacts;- unable to match z locations on prescan and 4d ct scan;- incorrect z annotation on plan box for coronal/sagittal surviews;- unintended change of acquisition timing on scan ruler;- bolus tracker does not trigger as expected; - system unresponsive when paused;- system becomes unresponsive during timed scan;- unplanned results during multi-phase pulmo series, may cause a system crash;- communication errors between host computer & gantry; and - pin wheel artefact using 0.67mm slice width.
Acción
Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
During post-quarantine packaging it was identified that the ifu for the statlock sheath stabilisation device for percutaneous sheath introducers was erroneously packaged with the mega and sensation plus iab catheter kits, instead of the ifu for the statlock catheter stabilisation device for iab catheters.
Acción
Maquet is advising users to inspect and identify the affected stocks. The IFU from the affected units should be removed and disposed prior to the use of the device. Affected customers can obtain a copy of the correct IFU by visiting the Maquet website at www.Maquet.com/statlockIFU , by scanning the QR code in the customer letter or by contacting the customer's local Maquet representative. This action has been closed-out on 11/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Johnson & johnson medical pty. ltd. (jjm) is issuing a medical device recall, in line with an ethicon initiated worldwide medical device removal, of ethicon physiomesh flexible composite mesh (for laparoscopic use).The product is being removed following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries.
Acción
Johnson & Johnson Medical advises customers to inspect stocks and immediately quarantine any affected units prior to their return. The management of patients who have been treated using ETHICON PHYSIOMESH Composite Mesh will remain at the discretion of the treating health care practitioner. A Hazard alert letter will be sent to Surgeons.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Device technologies australia (dta) in conjunction with the manufacturer, is issuing this warning notice in relation to the use of da vinci xi 5mm-8mm universal cannula seal and da vinci xi 12mm & stapler universal cannula seal in all surgical procedures.During internal inspections, intuitive surgical has identified particulate in the insufflation stopcocks on the da vinci xi 5mm-8mm universal cannula seal. the particulate generated from the seal material has the potential to be introduced into the cannula lumen when insufflation is connected. there have been no injuries reported related to this issue.
Acción
Users are advised to not use the da Vinci Xi 5mm-8mm Universal Cannula Seal or the da Vinci Xi 12mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during all types of surgical procedures until this issue is resolved. It is recommended to use an alternative device such as an angio-catheter, Veress needle or laparoscopic trocar for initial access and to maintain insufflation throughout all procedures as an alternative to insufflation through the da Vinci Xi 5mm-8mm Universal Cannula Seal (INS-470361) or the da Vinci Xi 12mm & Stapler Universal Cannula Seal (INS-470380). This action has been closed-out on 20/02/2017.