Events

Rappel de Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)

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-00467-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-17
  • 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-00467-1
  • 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 manufacturer found that if the headphone jack is in use during a surgical procedure with the ocs2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.
  • Action
    Integra is advising users that the device may still be used providing the audio jack is not used. An Integra representative will contact affected customers to arrange for the disabling of the audio jacks and prevent the problem occurring. No reports of this issue have been received from the field.

Device

Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)
  • Modèle / numéro de série
    Integra Ojemann Cortical Stimulator (Electrical antiseizure brain stimulator)Catalogue number: OCS2All serial numbers affectedARTG number: 150717
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd