Device Recall Covidien Endo GIA 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
    64420
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1063-2013
  • 사례 시작날짜
    2013-02-11
  • 사례 출판 날짜
    2013-04-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-03-20
  • 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
    Endo GIA AutoSuture Universal Loading Unit - Product Code GDW
  • 원인
    Single use loading unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention.
  • 조치
    Covidien notified customers with an Urgent Medical Device Recall notification on February 11, 2013. The letter identified the affected product and the reason for the recall. Accounts were requested to quarantine and discontinue use of the affected devices, and notify Universal Loading Unit 30mm-2.0mm users of this recall. Customers should follow the instructions provided in order to return the affected product. Customers are to complete and return the Product Return Form regardless if they have any affected product or not. For questions regarding the RGA I return process, please contact Covidien Customer Service, M-F, 8 am - 6:30 pm ET at (800) 962-9888, option 1, and then option 2.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
  • 제품 설명
    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm || Product Code: 030450 || Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
  • 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