Events

Retiro De Equipo (Recall) de ENDOPATH ETS-FLEX45

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
    2009-04-16
  • 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/rappel-de-lots-du-dispositif-medical-agrafeuses-lineaires-endoscopiques-articulees-endopath-ets-flex45-ethicon-endo-surgery-ethicon-sas
  • 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    On 09/04/2009, the company ETHICON SAS has withdrawn from the market the batches having an expiry date between September 2013 and February 2014 of the references 6TB45, ATG45, NAW45, ATB45, ATW45, LONG45A of the medical device called endoscopic endoscopic staplers ENDOPATH ETS-FLEX45 Ethicon Endo-surgery. Indeed, as a result of several claims, Ethicon Endo-Surgery has identified that some of these products had a defect in the articulation of the jaws at the end of the axis. In some cases this defect leads to the impossibility of opening the jaws of the stapler after they have been closed on the tissues. When the jaws can not be re-opened, the necessary steps to remove the stapler can lengthen the surgical procedure by increasing the operating time, handling the tissues and modifying the technique first. The company ETHICON SAS has directly notified the recipients of the incriminated lots with the message attached (16/04/2009) (290 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

ENDOPATH ETS-FLEX45
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon