Events

Large Clip Applier for use with the da Vinci STM and da Vinci SiTM 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-2014-RN-00759-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00759-1
  • 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
    Intuitive surgical inc. have become aware of the larger clip applier instrument jamming or feeling friction during insertion into the 8mm cannula or into certain cannula reducer accessories. no adverse events have been reported due to this issue. if an instrument gets jammed in the cannula or reducer accessory during insertion this may prevent or delay the use of the instrument. as the type of clip applied by the clip applier is used to occlude controlled vessels rather than during episodes of active bleeding, a delay in clip application will have no immediate or long term health consequences for the patient.
  • 조치
    A software update has been developed to correct the issue. The product may continue to be used while software upgrades are being made in the field. The software upgrade will reduce the degree to which the jaws on the Large Clip Applier Instrument open during insertion and will eliminate the occurrence of jamming.

Device

Large Clip Applier for use with the da Vinci STM and da Vinci SiTM

Manufacturer

Device Technologies Australia Pty Ltd