Device Recall Covidien Duet TRS Loading Unit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Covidien LP 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
    63015
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2433-2012
  • 사례 시작날짜
    2012-08-21
  • 사례 출판 날짜
    2012-09-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Staple, implantable - Product Code GDW
  • 원인
    Duet trs may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
  • 조치
    Covidien issued an "URGENT MEDICAL DEVICE RECALL" letter dated August 21, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm sent a revised customer recall notification letter via FedEx overnight delivery to all customers who purchased Duet TRS" devices from August 2009- August 2012. This letter went to all customers whether they had been sent the August 21st letter or not. Users were advised that Covidien was recalling all lots of the Duet TRS Universal Straight and Articulating Single Use Loading Units (SULU). On August 23rd 2012, Covidien notified, via e-mail, perspective surgeons that were planning to participate in the "Duet TRS Patient Registry" of the recall and that as a result the Duet TRS registry program was discontinued. Customers were asked to complete and return a Recalled Product Form via fax to (800) 895-6140. Contact Covidien Customer Service at (800) 722-8772, option 1 for questions regarding this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    All lot numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. || Product Code: DUET6048A. || Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
  • 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
    USFDA