Events

Alerte De Sécurité sur Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS Hemorrhoidal Circular Staple and Accessories 33mm

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 Endo-Surgery.

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
    2012-08-06
  • Date de publication de l'événement
    2012-08-06
  • 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_20120806.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 endo-surgery proximate® pph hemorrhoidal circular stapler and accessories 33mm and proximate® hcs hemorrhoidal circular staple and accessories 33mm medical device manufacturer, ethicon endo-surgery, has initiated a global voluntary recall for specific production lots of proximate® pph hemorrhoidal circular stapler and accessories 33mm (product code pph03) and proximate® hcs hemorrhoidal circular stapler and accessories 33mm (product code pph01) due to difficulty in firing the device which may result in incomplete firing stroke that may lead to an incomplete staple formation. the manufacturer advised all users to discontinue use of affected products. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 august 2012.

Device

Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ethicon Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS Hemorrhoidal Circular Staple and Accessories 33mm
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery