Events

Alerte De Sécurité sur Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II

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

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
    2016-07-18
  • Date de publication de l'événement
    2016-07-18
  • 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_20160718b.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: synthes adapter for colibri and small adapter for colibri ii and small battery drive and small battery drive ii medical device manufacturer, synthes, has issued a medical device safety alert concerning the following devices: adapter for colibri for electric pen drive; b) adapter, small, for colibri (ii) and small battery drive (ii) part number: a) 05.001.024 and b) 05.001.108 according to the manufacturer, there is a potential for the adapter for colibri and small adapter for colibri ii and small battery drive and small battery drive ii to generate excessive internal pressure that may cause the respective products to burst. the captioned device could cause permanent injury to the user and/or patient. although preliminary internal tests for this failure mode have determined this scenario is highly unlikely to occur, the manufacturer has decided to remove these products from the field. 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 july 2016.

Device

Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Dr...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II
  • Manufacturer
    Synthes

Manufacturer

Synthes