Events

VCARE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed 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
    49406
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0177-2009
  • 사례 시작날짜
    2008-09-08
  • 사례 출판 날짜
    2008-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73265
  • 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
    Cannula - Product Code LFK
  • 원인
    The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. it was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
  • 조치
    The domestic recall notices were mailed on 9/08/08 by USP Priority Mail pouches. The international notices were sent via FedEx International Priority on 9/08/08. The letter described the problem, the health risk and requested that customers inventory the product and return them back to the firm. Customers are requested to fax the reply form to the firm. Contact ConMed Corporation at 1-800-765-8375, ext 3237 for assistance.

Device

VCARE
  • 모델명 / 제조번호(시리얼번호)
    Lots 0710121x through and including 0804111x [yymmddx where x = shift code 1,2, or 3] . All lots of the recalled devices were manufactured between and including October 12, 2007 and April 11, 2008.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
  • 제품 설명
    VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60-6085-102. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE¿ Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • 제조사 주소
    ConMed Corporation, 525 French Road, Utica NY 13502
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA