Events

Rappel de Devon Light Glove (Used as a cover with a compatible surgical light handle)

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-2016-RN-01291-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-06
  • 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-2016-RN-01291-1
  • 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
    Customers have reported that on rare occasion (complaint rate less than 2/100,000 or 0.0017%), the devon light glove may split upon application to the devon light handle adapter. a subset of these splits reportedly resulted from a difficult application of the glove to the handle adapter. a split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. there have been no reports of serious injury associated with these rarely occurring splits.
  • Action
    Medtronic is adding the statement "After application, inspect the Light Glove for barrier integrity" to the Devon Light Glove Instructions for Use (IFU) and notifying this information to the users through the customer letter.

Device

Devon Light Glove (Used as a cover with a compatible surgical light handle)
  • Modèle / numéro de série
    Devon Light Glove (Used as a cover with a compatible surgical light handle)3611 Flexbl Lite Glove 1ea/pkgProduct Code: 311402083613 Lite GLV-Flexible 3ea/pkgProduct Code: 311402163612 Lite GLV-Flexible 2ea/pkgProduct Code: 31140257ARTG Number: 186761
  • 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