Events

Rappel de Device Recall Covidien Duet TRS Loading Unit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Covidien LP.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63015
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2433-2012
  • Date de mise en oeuvre de l'événement
    2012-08-21
  • Date de publication de l'événement
    2012-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112271
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Staple, implantable - Product Code GDW
  • Cause
    Duet trs may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
  • Action
    Covidien issued an "URGENT MEDICAL DEVICE RECALL" letter dated August 21, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm sent a revised customer recall notification letter via FedEx overnight delivery to all customers who purchased Duet TRS" devices from August 2009- August 2012. This letter went to all customers whether they had been sent the August 21st letter or not. Users were advised that Covidien was recalling all lots of the Duet TRS Universal Straight and Articulating Single Use Loading Units (SULU). On August 23rd 2012, Covidien notified, via e-mail, perspective surgeons that were planning to participate in the "Duet TRS Patient Registry" of the recall and that as a result the Duet TRS registry program was discontinued. Customers were asked to complete and return a Recalled Product Form via fax to (800) 895-6140. Contact Covidien Customer Service at (800) 722-8772, option 1 for questions regarding this recall.

Device

Device Recall Covidien Duet TRS Loading Unit
  • Modèle / numéro de série
    All lot numbers
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. || Product Code: DUET6048A. || Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Adresse du fabricant
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • 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
    USFDA