Events

Rappel de Endo GIA Ultra Universal Stapler Handles (Short, Standard & XL versions)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien Pty Ltd.

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
    RC-2015-RN-01197-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01197-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    This recall is being conducted following customer reports of instruments failing to fire or partially firing and reports of the instrument's articulating lever disengaging during use. if the instrument fails to fire or partially fires, or if the articulating lever disengages, there is a potential for minor bleeding should partial fire occur on vasculature and extended procedure time if an alternate device is not readily available. there is a rare potential for conversion from a laparoscopic procedure to an open procedure if the hospital does not have another functioning device from the sponsor or from another vendor. no patient injuries related to these issues have been reported.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return. This action has been closed-out on 5/12/2016.

Device

Endo GIA Ultra Universal Stapler Handles (Short, Standard & XL versions)
  • Modèle / numéro de série
    Endo GIA Ultra Universal Stapler Handles (Short, Standard & XL versions)Multiple Lot Numbers affectedARTG Number: 178675
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 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
    DHTGA