Events

Alerte De Sécurité sur Duet TRS™ Universal Straight and Articulating Single Use Loading Units

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

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
    2012-01-16
  • 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_20120116.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
    Field safety notice: recall of covidien duet trs™ universal straight and articulating single use loading units medical device manufacturer, covidien, is conducting a voluntary recall for all production lots of duet trs™ universal straight and articulating single use loading units with respect to the use of this product family in the thoracic cavity. covidien has received reports of 3 deaths and 13 serious injuries following the application of duet trs™ loading units in the thoracic cavity. covidien concluded that duet trs™ loading units has the potential to injure adjacent anatomical structures within the thorax which may result in life threatening post-operative complications. there have been no reports of adverse event in hong kong. the manufacturer advised that users should not use the device in thoracic surgery in both adult and paediatric populations. users may continue to use the device in other applications. according to the local supplier, the affected product has been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Duet TRS™ Universal Straight and Articulating Single Use Loading Units
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Recall of Covidien Duet TRS™ Universal Straight and Articulating Single Use Loading Units
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH