Events

Recall of Gynecare VERSAPOINT hysteroscopic bipolar electrosurgical system

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Ethicon.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2004-12-24
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-cables-de-connexion-versapoint-de-la-societe-ethicon
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    On December 22, 2004, the company Ethicon removed from the market the batches (appearing in annex 1 attached) of the reference 00480 of the medical device called "Connection cable of the Gynecare VERSAPOINT hysteroscopic bipolar electrosurgical system" following a risk of deformation after sterilization of the distal handpiece of the connecting cable, which can lead to difficult cleaning and compromise re-sterilization (this cable can be sterilized several times - the details are specified in the instruction manual of the device) .. The company has directly notified the users of the lots affected by this recall using the message validated by Afssaps (22/12/2004) (34 KB). This information is addressed to wardens and local correspondents of materiovigilance for dissemination to the services concerned. The competent European authorities have been informed of this measure by the manufacturer.

Device

Gynecare VERSAPOINT hysteroscopic bipolar electrosurgical system
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon