Events

Retiro De Equipo (Recall) de Gynecare VERSAPOINT hysteroscopic bipolar electrosurgical system

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Ethicon.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2004-12-24
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    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
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon