Events

Rappel de Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences 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-2017-RN-01276-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-11
  • 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-2017-RN-01276-1
  • 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
    Integra neurosciences has been advised that certain lots of footswitch supplied with the cusa clarity console may be faulty.A faulty footswitch may result in unintended ultrasonic fragmentation activation. there are two scenarios during which the failure mode may occur:1. ultrasonic fragmentation may be activated after set-up is complete and the user goes to the main screen (without the footswitch pressed); and/or2. ultrasonic fragmentation may remain activated during surgical use once the footswitch amplitude pedal is disengaged.There have been no adverse events or injury reported.
  • Action
    Integra is advising users to quarantine the affected units from use. Affected units will be replaced with unaffected stock.

Device

Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000
  • Modèle / numéro de série
    Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000Catalogue Number: C7002Lot Numbers: 1885744, 1923802, 1985221, 2057996, 2109587 and 2118507ARTG Number: 283158
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd