Events

Device Recall Signia Power Handle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Covidien LLC 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
    79483
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1237-2018
  • 사례 시작날짜
    2017-12-13
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162438
  • 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
    Product reportedly shutting down during use.
  • 조치
    The firm, Medtronic, sent a "Field Corrective Action Notice" dated 12/13/2017 to all consignees via Federal Express or certified mail on 12/13/17. The notice described the product, problem and actions to be taken. Customers were instructed to: immediately notify all users of Signia power handles of this important notification; follow the User manual and Instructions for Use; If your facility has distributed Signia" power handles to other persons or facilities, please promptly forward a copy of this letter to those recipients, and complete and return the Field Corrective Action Acknowledgement Form via Fax to (203) 492-7719 or email to: FCAMITG@Medtronic.com. All in-control inventory and product at customers locations will have the software update installed. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Device

Device Recall Signia Power Handle
  • 모델명 / 제조번호(시리얼번호)
    SIGPHANDLE-UDI 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  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (Nationwide).
  • 제품 설명
    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) || The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • 제조사 주소
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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
    USFDA