Events

Retiro De Equipo (Recall) de Device Recall Nitinol TC Reusable Electrodes (TCN)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cosman Medical, LLC.

¿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
    78704
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0687-2018
  • Fecha de inicio del evento
    2017-07-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160150
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Probe, radiofrequency lesion - Product Code GXI
  • Causa
    After multiple reprocessing cycles, the epoxy resin which holds the tcn electrode in the hub can exhibit signs of damage. in some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.
  • Acción
    The firm, Cosman Medical, sent an "Urgent Medical Device Correction" notice and Field Correction Reply Verification Tracking Form dated July 5, 2017 to their customers. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following: 1. Immediately discontinue use of devices that have already been used. Used TCN Electrodes should be disposed of in accordance with your institutions infectious material/biohazard waste control procedures. 2. Unused/un-opened TCN Electrodes should be identified as single use only (for one patient). These devices are supplied as non-sterile which require cleaning and sterilization prior to use. These TCN Electrodes may be used once the cleaning and sterilization steps are completed. After single use, the used TCN Electrode should be disposed of in accordance with your institutions infectious material/biohazard waste control procedures. 3. Complete and return the Field Correction Reply Verification Tracking Form. via Email: Cosmanorders@bsci.com or via Fax to: 781-272-6563 - Identify your email with TCN Electrodes Action in the subject line. Customers with questions may call 1-888-8COSMAN or email Cosmanorders@bsci.com.

Device

Device Recall Nitinol TC Reusable Electrodes (TCN)
  • Modelo / Serial
    All TCN electrodes with model numbers below.  Cat # TCN-10 Lot # 4717 4745 4851 4852 4916 5061 5193 5196 5372 5375 6111 6112 6627 6740 6746 6747 6819 6925 7525 7526 7806 8294 8422 8583 8942 9148 9327 9373 9374 9574 9978 A041 A143 A415 A435 A785 A797 B060 B061 B202 B264 B437 B814 B815 B901 B902 B903 C526 C527 C834 C846 D025 D157 D158 D238 D239 D602 D656 D685 D686 D946 D947 E129 E360 E382 E409 E410 E583 E714 E718 E886 E974 F074 F086 F101 F104 F112 F113 F178 F227 F228 F365 F366 F367 F368 F427 F428 F429 F555 F708 F709 F710 F711 F790 F791 F887 F888 F889 G007 G008 G116 G118 G119 G120 G152 G170 G171 G172 G352 G963 H011 H012 H016 H088 H089 H284 H347 H487 H488 H507 H595 H850 H872 H932 I011 I012 I056 I057 I145 I146 I236 I237 I246 I247 I294 I400 I401 I402 I448 I449 I450 I451 I547 I548 I580 I616 I617 I841 I842 I918 I919 I959 J008 J102 J180 J181 J306 J307 J308 J560 J561 J680 J808 J810 J811 J958 J959 K165 Cat # TCN-10-3M Lot # B463 B612 C711 D430 D781 E414 E508 E618 E972 F426 F523 F604 F788 G075 G383 G413 G611 G761 G764 G826 G968 H085 H093 H286 H324 H345 H496 H582 H614 H735 I013 I578 I619 I751 J511 J515 J563 J682 J730 Cat # TCN-15 Lot # 4746 4854 4901 4917 5060 5194 5197 5373 5376 5557 6741 6820 7227 8295 8943 9165 9386 9575 A078 A416 A434 B062 B438 B904 C060 C212 C285 C845 D240 D241 D603 D950 E133 E381 E411 E584 E715 E970 F072 F183 F229 F369 F396 F430 F431 F712 F713 F789 F890 F891 G000 G169 G440 G943 G952 H004 H090 H285 H508 H594 H608 I399 I409 I452 I453 I549 I579 I615 I843 I920 I960 J101 J182 J310 J562 J681 J812 J813 J960 J961 Cat # TCN-15-3M Lot # B613 C707 E509 F714 G168 H094 H287 H325 H346 I752 J564 Cat # TCN-20 Lot # H091 J183 5077 5199 5558 6821 6832 6924 8944 9576 Cat # TCN-5 Lot # A417 A786 B439 C528 D242 D687 D945 E130 E625 E887 F076 F201 F230 G266 G762 H015 H092 H619 I144 I618 J100 J184 J309 J731 4747 4853 4918 5062 5195 5198 5374 5377 6748 6822 7640 8945 9577 Cat # TCN-5-3M Lot # B614 D024 F946 G076 H095 J886
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and country of Canada.
  • Descripción del producto
    Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*. || The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.
  • Manufacturer
    Cosman Medical, LLC

Manufacturer

Cosman Medical, LLC
  • Dirección del fabricante
    Cosman Medical, LLC, 22 Terry Ave, Burlington MA 01803-2516
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA