Events

Rappel de CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator

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-2013-RN-01300-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-10
  • 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-2013-RN-01300-1
  • 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 notified by the manufacturer that there may be the potential that the blue coag button on the cusa excel cem nosecone could stick in the 'activated' position. a small number of complaints where this has occurred have been reported and of those, a smaller number resulted in tissue burn.
  • Action
    Integra is providing an Update to the Instructions for Use (IFU). Integra is advising users to replace nosecone if the COAG button is observed to be sticking and contact Integra. Integra is advising users to check the nosecone during setup and prior to patient use and replace nosecone if observed to be sticking. If the Nosecone is to be used in excess of approximately 30 minutes during surgery, Integra is advising to replace the nosecone after 30 minutes of activation.

Device

CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
  • Modèle / numéro de série
    CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic AspiratorCatalogue Numbers: C6623 and C6636Lot Numbers: All lotsARTG Number: 197945
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd