Events

da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards 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-2018-RN-00231-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00231-1
  • 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 become aware that circuit boards in specific da vinci x surgical system arms are susceptible to early failures that may result in system faults. the affected arms include arm controller joint circuit boards manufactured with components from a specific manufacturing lot that, due to manufacturing variations, may fail prematurely.As indicated in the user manual, if an arm-specific fault occurs on a system during a procedure and the fault cannot be recovered, the affected arm can be disabled and the procedure may be continued with three arms.If a fault that is not arm-specific occurs, restarting the system may clear the fault. however, the fault may recur. the user may then decide to abort the da vinci procedure or convert to an alternate surgical method.There have been no patient injuries as a result of this issue.
  • 조치
    Device Technologies will be replacing the affected Arm Controller Joint Circuit Boards as a permanent correction.

Device

da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards
  • 모델명 / 제조번호(시리얼번호)
    da Vinci X Patient Side Cart Arm Controller Joint Circuit BoardsModel Number: IINS-IS4200Serial Number: SL0015ARTG Number: 97348(Device Technologies Australia - Robot, surgical, operation unit)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd