Events

Retiro De Equipo (Recall) de TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia 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-2013-RN-01048-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-10
  • 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-2013-RN-01048-1
  • 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
    Two batches of silicone potting have been identified by the supplier as having cure properties that were outside of the specified range. the potting material is used to insulate, stabilise and provide a moisture barrier to the main printed circuit board assembly (pcba) of the tps microdriver. inadequate curing of the silicone potting creates the possibility for silicone potting to leak outside of the handpiece and cause electrical malfunction.
  • Acción
    Stryker is requesting users to inspect and quarantine devices from the affected lot numbers. Affected devices are to be returned to Stryker for repair before returning to the customers. Stryker will provide a loan unit to be used until the device is repaired.

Device

TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins,...
  • Modelo / Serial
    TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)Catalogue Number: 5100088000Lot Numbers: 0921700523, 0723606673ARTG Number: 139725
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA