Events

da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systems 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-01310-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01310-1
  • 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 has received 66 unique adverse event reports associated with product use scenarios that were not previously addressed in labelling for the da vinci s, si or si-e surgical system, instruments and accessories.Intuitive surgical is initiating a correction related to labelling updates to distributed user manuals, instructions for use (ifu), quick reference guides (qrg)and the natural rubber latex qrg as well as an instrument release kit (irk) for use with da vinci surgical systems, instruments and accessories. the labelling updates have been implemented to incorporate user feedback not previously addressed.
  • 조치
    Device Technologies is advising their customers of the changes to labelling and requesting that superseded versions are discarded and replaced with the updated product information. End users are also requested to discard the Emergency Grip Release Wrench and replace with the Instrument Release Kit which includes the release wrench and an attached instruction card. This action has been closed-out on 14/07/2016.

Device

da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vi...
  • 모델명 / 제조번호(시리얼번호)
    da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systemsAll Serial Numbers are affected Model Numbers: IS1200, IS2000, IS3000 ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd