Events

Intuitive Surgical da Vinci Patient Side Manipulators 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Intuitive Surgical Inc 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
    15753
  • 사례 시작날짜
    2013-11-28
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 원인
    Manufacturer has become aware that friction within certain instrument arms can interrupt smooth instrument motion. this interruption is felt by by the surgeon as resistance in the movement of the master. in this situation the instrument can stall momentarily and then suddenly catch-up to the master psition id the surgeon pushes through the resistance. this resistance is most noticeable when moving the instruments at very slow speeds and during small movements of the masters. this system behaviour is not autonomous instrument motion.
  • 조치
    Product to be modified

Device

Intuitive Surgical da Vinci Patient Side Manipulators
  • 모델명 / 제조번호(시리얼번호)
    Model: da Vinci S, Si and Si-e Patient Side cart, Affected:
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc