Events

Alerte Ou Avis De Sécurité sur Stapler Duet TRS™ universal straight and articulating single use loading units (SULU)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom 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
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2012/005
  • Date
    2012-02-16
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-stapler-duet-trs-universal-straight-and-articulating-single-use-loading-units-sulu-do-not-use-for-adult-or-paediatric-thoracic-surgery-procedures
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory 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 recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
    Covidien has issued advice (369Kb) following reports of serious injuries that have occurred following the use of these devices in the thoracic cavity.These stapler loading units have the potential to injure adjacent anatomical structures within the thorax, which may result in life threatening post-operative complications.
  • Cause
    (covidien) reports of serious injuries after use of stapler duet trs™ loading units in the thoracic cavity.(mda/2012/005).
  • Action
    Do not use these Duet TRSTM Loading Units for any adult or paediatric thoracic surgery procedures. Return any products purchased solely for thoracic use to the manufacturer, following the instructions in the manufacturer’s advice (369Kb).

Device

Stapler Duet TRS™ universal straight and articulating single use loading units (SULU)
  • Modèle / numéro de série
  • Description du dispositif
    StaplerDuet TRS™ universal straight and articulating single use loading units (SULU)Manufactured by CovidienProduct codes and descriptions of affected devices:Product code   Description DUET4535   Duet TRS™ 45 3.5mm straight SULU DUET4535A   Duet TRS™ 45 3.5mm articulating SULU DUET4548   Duet TRS™ 45 4.8mm straight SULU DUET4548A   Duet TRS™ 45 4.8mm articulating SULU DUET6035   Duet TRS™ 60 3.5mm straight SULU DUET6035A   Duet TRS™ 60 3.5mm articulating SULU DUET6048   Duet TRS™ 60 4.8mm straight SULU DUET6048A   Duet TRS™ 60 4.8mm articulating SULU
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Adresse du fabricant
    Amanda Woolven Covidien Commercial (UK) Ltd 4500 Parkway Whiteley Hampshire PO15 7NY Tel: 01329 224 435 Fax: 01329 224 418Email: Amanda.woolven@covidien.com
  • 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
    MHRA