Events

Recall of ENDOPATH® endoscopic instruments of 5 and 10 mm.

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 Endosurgery.

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
    2004-12-21
  • 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-d-instruments-endoscopiques-endopath-r-de-la-societe-ethicon-endosurgery
  • 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 20, 2004, the company Ethicon Endosurgery removed from the market all the lots that expired in June, July, August and September 2009 from references 10BB, 10AG, 5BB and 5DSG of the medical device called ENDOPATH® endoscopic instruments of 5 and 10 mm. as a result of a risk of assembly failure at the handle which may result in a loss of functionality of the push button. The company has directly notified the users of the batches concerned by this recall with the attached message (20/12 / 2004) (36 KB) validated by Afssaps. 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

ENDOPATH® endoscopic instruments of 5 and 10 mm.

Manufacturer

Ethicon Endosurgery
  • Source
    LAANSM