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
    2012-08-24
  • Date de publication de l'événement
    2012-08-24
  • 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_20120824a.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: covidien duet™ trs universal straight and articulating single use loading units medical device manufacturer, covidien, is conducting a voluntary recall of all production lots for the duet trs™ universal straight and articulating single use loading units (sulu). in addition, the company has discontinued manufacturing the duet trs™ universal straight and articulating sulu. serious injuries and/or deaths could occur due to the failure mode associated with this recall. covidien has received one report that links the duet trs™ tissue reinforcement material to a postoperative injury after abdominal surgery. the company has concluded that duet trs™ may have the potential to injure adjacent anatomical structures, which may result in life threatening postoperative complications. specifically, exposed edges of tissue reinforcement material may cause lacerations, punctures or trauma to adjacent anatomical structures resulting in pain, bleeding or other post-operative complications. this is in addition to the recall conducted in january of 2012 which contra-indicated the use of duet trs™ for thoracic surgery. at that time, covidien received reports of thirteen serious injuries and three deaths, following the application of duet trs™ in the thoracic cavity. 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. posted on 24 august 2012.

Device

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