Events

Large and Mega Needle Driver Endowrist Instruments for 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-2013-RN-01294-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01294-1
  • 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 of the potential for detachment of the jaw insert for large needle drivers and mega needle drivers. only large needle driver and mega needle driver instruments manufactured between july 2007 and october 2011 are affected. if a jaw insert detaches during surgery, this could result in a device fragment falling into the patient.
  • 조치
    Device Technologies is advising users to quarantine affected devices from use. Affected devices can be returned to Device Technologies.

Device

Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical Systems
  • 모델명 / 제조번호(시리얼번호)
    Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical SystemsLarge Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420006Mega Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420194Large Needle Driver, da Vinci StandardProduct Number: INS-400006Mega Needle Driver, da Vinci StandardProduct Number: INS-400194.Multiple Lot Numbers affectedManufactured between July 2007 and October 2011ARTG Number: 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd