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-00046-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-01-17
  • 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-00046-1
  • 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 since 2009 they have received a small number of complaints for cusa tip breakage. the manufacturer's investigation of these complaints identified that when the tips are used under specific circumstances with the cem nosecone, there is the potential for erosion of the cusa tip. the erosion can potentially lead to tip breakage.Specifically, the potential for cusa tip erosion occurs only during cem operation and if the side of the tip, rather than the annulus of the tip, is in contact with the tissue.
  • Action
    Integra Neurosciences Pty Ltd is revising the package insert to include an additional warning advising users to ensure that only the CEM Nosecone contacts the intended tissue at the annulus of the tip and not the side of the tip to avoid tip breakage.

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, C6636All lot numbers affectedARTG Number: 197945
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd