Events

Recall of ENDOPATH ETS-FLEX45

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
    2009-04-16
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    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
  • 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    On 09/04/2009, the company ETHICON SAS has withdrawn from the market the batches having an expiry date between September 2013 and February 2014 of the references 6TB45, ATG45, NAW45, ATB45, ATW45, LONG45A of the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
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon