Events

Alerte De Sécurité sur ENDOLOOP Product Code EH496

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Ethicon.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-04-18
  • Date de publication de l'événement
    2016-04-18
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160418b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: ethicon endoloop product code eh496 medical device manufacturer, ethicon, has issued a medical device safety alert concerning its endoloop product code eh496. this involves all the batches of endoloop product code eh496 manufactured since 2010. during ongoing stability testing, it was determined the average knot pull tensile strength in some of the batches was below the specification limit. however, the potential safety risks due to such below average knot pull tensile strength are mitigated by the fact that all the individual strands that were tested met the minimum values of knot pull tensile strength. according to the manufacturer, no complaints related to infection or any wound dehiscence has been reported from the batches manufactured with these casings. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2016.

Device

ENDOLOOP Product Code EH496
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ethicon ENDOLOOP Product Code EH496
  • Manufacturer
    Ethicon

Manufacturer

Ethicon