Events

Retiro De Equipo (Recall) de Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00795-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-15
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00795-1
  • Notas / Alertas
    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
    This action is being taken to mitigate the risk of injury associated with the potential for leakage of fluid into the motor through the rocker housing seal. the seal is intended to prevent ingress of fluid into the sagittal microsaws during use and decontamination. although there have been no reports of fluid leakage occurring in the field, engineering testing of the seal identified the potential for leakage to occur. in assessing the risk of this potential failure, testing was conducted that indicated the gravity displacement sterilisation cycle which is included in the ipc user manual may not be adequate to ensure sterility of internal motor components if fluid ingress occurs beyond the rocker housing seal. in the event that fluid leaks into the motor through the rocker housing seal, and gravity displacement sterilisation method is used, if fluid leaks from the motor during use and this fluid contacts the patient surgical site, there is a potential for infection to occur.
  • Acción
    Customers are advised to check their inventory for the affected products. A Medtronic Representative will be in touch with customers to organise the return of this product. This action has been closed-out on 17/02/2017.

Device

Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System)
  • Modelo / Serial
    Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System)Saw SagittalItem Number: ES300Saw Sagittal, RefurbishedItem Number: ES300-RSaw Sagittal, FingerItem Number: ES310Saw Sagittal, Finger, RefurbishedItem Number: ES310-RAll Serial Numbers affectedARTG Number: 200336
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA