Events

Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2015-RN-01110-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01110-1
  • 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
    Under rare circumstances, grip actuated instruments may become fixed in a closed position. this potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula, which may result in: 1. a break in the roll gear and/or instrument shaft 2. damage to the push/pull mechanism that controls grip opening and closingif a da vinci si single-site instrument grip cannot be released normally or by opening the masters or the instrument release kit (irk), the surgeon may need to excise tissue in order to extract the instrument.
  • 조치
    The customer is to inspect and remove any instrument that shows signs of damage. If the instrument grips remain closed on tissue during surgery and the IRK cannot be used, the surgeon is to follow the instructions in the User Manual addendum to manually release the grip. The sponsor is to arrange the return of the product and credit. This action has been closed-out on 18/04/2017.

Device

Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism

Manufacturer

Device Technologies Australia Pty Ltd