Events

Alerte De Sécurité sur Soft Tissue Retractor, small, extendible

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 GmbH.

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
    2013-05-08
  • Date de publication de l'événement
    2013-05-08
  • 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_20130508d.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 soft tissue retractor, small, extendible medical device manufacturer, synthes gmbh, has issued a field safety notice concerning soft tissue retractor, small, extendible with part number 325.101. synthes received complaints about tip breakage/locking nut malfunction. retrieval of device fragments intraoperatively and delayed surgical procedure have been reported as a result of locking nut malfunction. unretrieved device fragments may result in an adverse tissue reaction, complaint events have been reported that required the removal of generated device fragments. no known adverse tissue reactions have been reported due to the presence of unretrieved device fragments. surgical delays have been reported due to device failure and the resulting time required for retrieving the device fragments. besides, the sudden loss of function, intraoperative breakage, of the soft tissue retractor has the potential to result in soft tissue irritation. 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 08 may 2013.

Device

Soft Tissue Retractor, small, extendible
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes Soft Tissue Retractor, small, extendible
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH