Events

Rappel de VCARE

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par ConMed Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49406
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0175-2009
  • Date de mise en oeuvre de l'événement
    2008-09-08
  • Date de publication de l'événement
    2008-10-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73263
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Cannula - Product Code LFK
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
  • Description du dispositif
    VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-000. 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
  • Adresse du fabricant
    ConMed Corporation, 525 French Road, Utica NY 13502
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    USFDA