Events

Alerte De Sécurité sur Nubac Trial Inserter – 43-TRL-INSERTER

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

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
    2012-05-03
  • Date de publication de l'événement
    2012-05-03
  • 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_20120503e.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: pioneer surgical nubac trial inserter – 43-trl-inserter it has come to our attention that medical device manufacturer, pioneer surgical technologies, has issued a field safety corrective action concerning nubac trial inserter – 43-trl-inserter. the manufacturer has identified that the affected device can wear causing it not to function as designed. this wear may cause the trial spacer to become detached from the inserter while in use. if this takes place, the trial spacer may be difficult to remove from the patient which may cause patient injury during this removal process. the manufacturer advised that the device should be inspected prior to every use and they have developed a test fixture to be used to assist in the determination of the wear of the device. if you are in possession of the affected product, please contact your supplier for necessary actions. posted 03 may 2012.

Device

Nubac Trial Inserter – 43-TRL-INSERTER
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Pioneer Surgical Nubac Trial Inserter – 43-TRL-INSERTER
  • Manufacturer
    Pioneer Surgical Technologies

Manufacturer

Pioneer Surgical Technologies