Events

Covidien Endo GIA Articulating Reloads with Tri-Staple Technology 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-00655-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-06-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00655-1
  • 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
    Medtronic has identified the potential for the device to have a misassembled (reversed) sled component. the sled component is responsible for staple deployment. when the device is applied to tissue and fired, a misassembled sled may result in the tissue being transected without the deployment of staples to seal the point of transection. this may result in bleeding, immediate anastomotic leak, and/or the potential for death if this is used on a critical vascular structure such as the pulmonary artery and renal artery. internationally, medtronic have received one report of injury related to this issue. to date, there have been no reported injuries in australia.
  • 조치
    Medtronic is advising customers to immediately discontinue use of the affected products. Unused product should be quarantined and returned to Medtronic by following the instructions outlined on the Customer Letter. Medtronic will arrange collection of stock from customers and issue a credit for returned goods.

Device

Covidien Endo GIA Articulating Reloads with Tri-Staple Technology
  • 모델명 / 제조번호(시리얼번호)
    Covidien Endo GIA Articulating Reloads with Tri-Staple TechnologyEndo GIA 45mm Articulating Medium/Thick Reload with Tri-Staple Technology Item Code: EGIA45AMT Lot: N7L0521KXARTG:181429 Endo GIA 45mm Extra Thick Black Articulating Reload with Tri-Staple TechnologyItem Code: EGIA45AXT Lots: N8A0907KX and N8A0146KX ARTG:181429Endo GIA 60mm Articulating Vascular/Medium Loading Unit with Tri-Staple TechnologyItem Code: EGIA60AVM Lot: N8B0088KX ARTG:186247
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia 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