Events

Avis De Sécurité sur Duet TRS Universal Straight and Articulating Single Use Loading Units (SULU) / DUET TRS Reload

Selon Swedish Medical Products Agency, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Sweden qui a été fabriqué par Covidien.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    444:2012/3565
  • Pays de l'événement
    Sweden
  • Source de l'événement
    SMPA
  • URL de la source de l'événement
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Instrument-kirurgi--Duet-TRS-Loading-units---Covidien1/#
  • Notes / Alertes
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 Sweden.
  • Notes supplémentaires dans les données
    DUET01-12
  • Action
    Updating the previously published information. New product name.

Device

Duet TRS Universal Straight and Articulating Single Use Loading Units (SULU) / DUET TRS Reload
  • Modèle / numéro de série
  • Description du dispositif
    Instrument - surgery
  • 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
    SMPA