Events

da Vinci Xi EndoWrist Stapler Release Kit (SRK) 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-00500-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00500-1
  • 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
    In march 2017, device technologies australia (dta) in conjunction with intuitive surgical sent correspondence (tga ref rc-2017-rn-00440-1) highlighting the proper use of the da vinci xi endowrist stapler release kit (srk) tool and providing additional information regarding the use of the instrument release kit (irk) tool as a backup if a srk tool was not available.Further to this, intuitive surgical has now developed an improved da vinci xi endowrist stapler release kit (srk) tool, which reduces the likelihood of breakage. please note that the instructions for use (ifu) remain the same.
  • 조치
    Device Technologies are advising they will be providing users with replacement SRK tool(s) of the new design. Two new SRK tools will be provided free of charge for each da Vinci Xi or da Vinci X customer using the EndoWrist Stapler system. Users should place all new SRK tools with their system and discard any previous versions in inventory. Additional SRK tools may be ordered via the standard ordering process. Users are reminded to refer to the IFU for appropriate use of the device.

Device

da Vinci Xi EndoWrist Stapler Release Kit (SRK)
  • 모델명 / 제조번호(시리얼번호)
    da Vinci Xi EndoWrist Stapler Release Kit (SRK)Product Name: IS4000 EndoWrist Stapler 45 – Stapler Release KitObsolete Product Code: INS-381215New Product Code: INS-381215-03Part Number: 381215-02ARTG Number: 228401(Device Technologies Australia - Wrench, surgical)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd