Events

Device Recall VirtoSaph Plus Endoscopic Vessel Harvesting System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corporation 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
    59189
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2854-2011
  • 사례 시작날짜
    2011-06-10
  • 사례 출판 날짜
    2011-07-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101568
  • 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
    General and plastic surgery laparascope - Product Code GCJ
  • 원인
    Terumo cardiovascular systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the virtuosaph plus endoscopic vessel harvesting system during cases in a limited production launch situation. teumo's investigation identified issues with the devices's capability to maintain pressure within the tunnel.
  • 조치
    Terumo Cardiovascular Systems contacted the one customer to this device on June 10, 2010 by telephone. There was one consignee. The firm contacted this one consignee by phone on 6/10/2010. There were 2 contacts at this one consignee. The recalling firm contacted both of the contacts on 6/10/2010. The consignee was asked to dispose of remaking inventory of devices. The consignee said had disposed of the product. For information on this recall call (734) 741-6173

Device

Device Recall VirtoSaph Plus Endoscopic Vessel Harvesting System
  • 모델명 / 제조번호(시리얼번호)
    Catalog #: VSP550 Lots: 0XK, 0YK, 09K.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) Distribution including the state of New York.
  • 제품 설명
    VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System || Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA