Events

Endo GIA Ultra Universal Stapler Handles (Short, Standard & XL versions) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Covidien 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-2015-RN-01197-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01197-1
  • 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
    This recall is being conducted following customer reports of instruments failing to fire or partially firing and reports of the instrument's articulating lever disengaging during use. if the instrument fails to fire or partially fires, or if the articulating lever disengages, there is a potential for minor bleeding should partial fire occur on vasculature and extended procedure time if an alternate device is not readily available. there is a rare potential for conversion from a laparoscopic procedure to an open procedure if the hospital does not have another functioning device from the sponsor or from another vendor. no patient injuries related to these issues have been reported.
  • 조치
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return. This action has been closed-out on 5/12/2016.

Device

Endo GIA Ultra Universal Stapler Handles (Short, Standard & XL versions)
  • 모델명 / 제조번호(시리얼번호)
    Endo GIA Ultra Universal Stapler Handles (Short, Standard & XL versions)Multiple Lot Numbers affectedARTG Number: 178675
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA