Events

SPYDER Anastomotic Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Cardiac Surgery Technologies 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
    33341
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0763-06
  • 사례 시작날짜
    2005-09-01
  • 사례 출판 날짜
    2006-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-04-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41718
  • 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
    Clip, Implantable - Product Code FZP
  • 원인
    Customers stated that the u-clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the u-clips.
  • 조치
    A letter and response certificate disseminated to all customers describing problem and recommending return of Spyder devices in inventory. September 1, 2005.

Device

SPYDER Anastomotic Device
  • 모델명 / 제조번호(시리얼번호)
    All units with Use Before Dates earlier than June, 2007.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide (AZ, CA, CT, FL, HI, IA, ID, IL, IN, KS, KY, LA, ,MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, TN, TX, UT, WA, WI, WV). Japan, Belgium, Netherlands, Singapore, and Thailand.
  • 제품 설명
    Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis.
  • Manufacturer
    Medtronic Cardiac Surgery Technologies

Manufacturer

Medtronic Cardiac Surgery Technologies
  • 제조사 주소
    Medtronic Cardiac Surgery Technologies, 7601 Northland Dr N, Minneapolis MN 55428-1088
  • Source
    USFDA