Events

Rappel de Device Recall VCare, Standard/Small/Large Cervical Cup

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
    57841
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1520-2011
  • Date de mise en oeuvre de l'événement
    2011-02-02
  • Date de publication de l'événement
    2011-03-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97537
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    Cannula, manipulator/injector uterine - Product Code L KF
  • Cause
    Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier instructions for use, ifu (pn 17416, rev. d) which does not contain the revisions on the addition of warning notes 10 and 11 and the expansion of warning note 6 to the vcare¿ instructions for use. the reason for the field correction is to provide a copy of the revised ifu to all customers who may have unexpired vcare¿.
  • Action
    ConMed Corporation sent a communication to provide its direct consignees with important supplemental information concerning the Instructions for Use (IFU) for the VCARE¿ Vaginal-Cervical Ahluwalia's Retractor-Elevator uterine manipulators. The direct consignees were instructed to place a copy of the enclosed Instructions for Use, Part No. 14071 (Rev. A), with any inventory in your possession with an expiration date prior to August 2011 (2011-08) and replace any other Instructions for Use in thier possession. A copy of the enclosed Instructions for Use is already packaged with all devices bearing later expiration dates. Any inventory in their consignees possession with an expiration date prior to January 2011 (2011-01) is expired and should not be used. If the devices were further distributed to other facilities or distributors, or their consignees are a distributor, they were instructed to forward this information as appropriate to any known users of these devices. For questions regarding this recall call 315-624-3225. --- The IFU Warning changes are as follows: A new warning statement # 6 asks the user to verify the presence of all the components of the device upon removal of the VCARE¿ device from the patient. Although the prior IFU contained warnings about verifying that all components of the device were properly removed following use during surgery, the new statement expands the earlier, briefer statement. 6. Upon removing VCARE, the surgeon should visually inspect the VCARE device, and the patient, to make sure that the entire VCARE device was properly removed and that no components or fragments of these components were retained in the patient. There are 5 parts/components to the VCARE Cervical Elevator Retractor. These are: 1) the balloon; 2) the forward "cervical" cup; 3) the back or vaginal cup; 4) the locking assembly with thumb screw; 5) the metal shaft and handle with balloon inflation valve. --- A new warning statement # 10 further addresses

Device

Device Recall VCare, Standard/Small/Large Cervical Cup
  • Modèle / numéro de série
    VCare¿ Standard Cervical Cup (Catalog # 60-6085-100), VCare¿ Small Cervical Cup (Catalog # 60-6085-101) and VCare¿ Large Cervical Cup (Catalog # 60-6085-102). Lot codes for product manufactured between 01/20/2009 (Lot 090120X) and through 07/31/2009 (Lot 090731X). Lot Code Key = YYMMDDX, where X = manufacturing shift (e.g. 1, 2 or 3)
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including NY, TX, CA, IA, AZ, PA, IN, and KS and the countries of Austria, Jordan, Turkey, China, Portugal, Chile, Belgium, Ecuador, Brazil, Romania, Japan, Malaysia, India Switzerland, Colombia, Netherlands, Spain, Saudi Arabia, France, and Canada.
  • Description du dispositif
    VCare¿ Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5" x 12" 12-page booklet and is packed loose in the carton. Only the carton will have to be opened to replace the old IFU; there is no need to open the sterile packaging of the individual VCare pouches. || 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