Events

TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-01048-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01048-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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,...
  • 모델명 / 제조번호(시리얼번호)
    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
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA