Events

Rappel de Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Cochlear 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-2014-RN-00452-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • 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-2014-RN-00452-1
  • 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
    The cochlear baha soft tissue gauge, part #95070 may have a manufacturing imperfection in the smooth surface of the metal. while this imperfection is minimal, cochlear's risk analysis has indicated that it could potentially leave residual metal on the patient’s skin. to date there have been no adverse events reported to cochlear associated with the use of this instrument.
  • Action
    Cochlear will remove and replace current Soft Tissue Gauge with an unaffected instrument as quickly as possible. This new instrument has passed additional inspection under microscope to ensure it is not affected by this issue. The instruments removed from the field will also be subjected to the additional inspection under microscope and, if unaffected, be returned for use as required. Any instruments failing additional inspection under microscope will be scrapped. There is no change to clinical management guidelines for patients who have had implant surgery using this instrument.

Device

Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit)
  • Modèle / numéro de série
    Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit) Part Number: 95070ARTG Number: 205705
  • Manufacturer
    Cochlear Ltd

Manufacturer

Cochlear Ltd