Events

Synthes Small Electric Drive Hand Piece (Drill Surgical System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Synthes 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-2014-RN-01278-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01278-1
  • 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
    It has been reported that the small electric drive (sed) may experience failure modes such as the device not functioning, the device operating solely in reverse mode, the device not operating in reverse when intended or an unintended start of the device. this may lead to surgical delays in the event the user requires a replacement power tool. an unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue damage, peripheral nerve damage and /or vascular damage because the hand piece has the potential to progress further into the surgical site when the operator is not intending this motion. these injuries may need surgical or medical intervention.
  • 조치
    Affected units are to be quarantined and returned as per the instructions in the Customer Letter. DuPuy Synthes will then provide a replacement at no charge in the form of a Colibri II (532.101) along with an electric adapter (05.001.1058) and a wire driver (532.022) to use instead of the Small Electric Drive. This action has been closed-out on 06/07/2016.

Device

Synthes Small Electric Drive Hand Piece (Drill Surgical System)
  • 모델명 / 제조번호(시리얼번호)
    Synthes Small Electric Drive Hand Piece (Drill Surgical System)Part Number: 05.001.175 All Lot NumbersARTG Number: 157072
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd