Events

Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system) 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-2013-RN-00390-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00390-1
  • 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
    The sterile adapter acts as an interface between the sterile surgical instruments and non-sterile system. intuitive surgical is undertaking market action to provide users of the da vinci s, si and si-e systems with additional information regarding sterile adapter engagement and instrument installation. although rare, sterile adapter and instrument engagement issues may lead to non-intuitive motion or a sluggish response when controlling instruments.
  • 조치
    Device Technologies is providing their customers with further training to ensure the correct engagement of the sterile adaptor. Additional quick reference instructions will also be provided.

Device

Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)
  • 모델명 / 제조번호(시리얼번호)
    Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)Model numbers: da Vinci S - IS2000da Vinci Si - IS3000da Vinci Si-e - IS3000Serial numbers: IS2000 IFU 550516-05; IS3000 IFU 550650-05
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd