Events

Device Recall VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE 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
    57735
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1230-2011
  • 사례 시작날짜
    2011-01-10
  • 사례 출판 날짜
    2011-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97290
  • 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
    Laparoscope, general &38; plastic surgery - Product Code GCJ
  • 원인
    The bipolar cord product specification indicates the product has a service life of 50 uses. however the ifu does not specify an end of service life. the firm has recieved 46 complaints on the bipolar cord. the firm investigated and found that the units involved in the complaints were often over 12 months old. the firm believes the units involved in the complaints were beyond their product life.
  • 조치
    Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE CORRECTION letter dated January 10, 2011, to Operating room managers. The letter informed the customers of the Bipolar cord product life of 50 uses. The letter states that the IFU for the bipolar cord is being updated to include the information regarding the limit of 50 uses and sterlization cycles. The letter recommends that user keep a sterile back up bi-polar cord in a convienent place during endoscopic vein harvesting procedures. The firm provided a tracking sheet in each package to help users track the number of sterlization cycles for the cord. Customers were instructed to review the Medical Device Correction notice, assure that all users were aware of the notice, and confirm receipt of the communicaiton by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call Terumo CVS Customer Service at 1-800-521-2818.

Device

Device Recall VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 4ZK, 51K, 52K, 53K, 54K, 55K, 6XK, 6ZK, 71K, 72K, 73K, 74K, 75K, 76K, 77K, 78K, 79K, 7XK, 7YK, 7ZK, 81K, 82K, 83K, 84K, 85K, 86K, 87K, 87K, 88K, 89K, 8XK, 8YK, 8ZK, 91K, 95K, 96K, 97K, 99K, 9XK, 9YK and 9ZK.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - United States including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, , NY, MO, MS, MT, NC, NE, NH, NJ, NM, OH, OK, OR, PA, SC, TN, TX, VA, WI, AND WV and the countries of Chile, Hong Kong, Malaysia, United Arab Emirates, Belgium, Japan, Korea, The Phillipines, Singapore, Taiwan, Thailand, Germany, and United Kingdom.
  • 제품 설명
    Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI. || The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated for use with the Terumo VirtuoSaph Endoscopic Vein Harvesting System and a compatible generator during saphenous vein harvesting procedures.
  • 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