Events

Rappel de HF-Resection Electrode

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Olympus Australia 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-2018-RN-00470-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-06-01
  • 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-2018-RN-00470-1
  • 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, olympus winter & ibe (owi) became aware of complaints relating to signs of wear on the handle after sterilization using the sterrad and steris, ‘casp low temperature plasma sterilizer’. during their investigation, the manufacturer confirmed that these signs of wear (slight changes in colour and structure) at the handle had occured after the first time of sterilization. whilst the sterilisation has no impact on the electrical safety of the electrodes, it no longer meets the manufacturer’s material compatibility acceptance criteria when using the sterrad and steris sterilisation methods. to ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the sterrad and steris sterilisation methods, as such the ifu has been updated to change the compatibility to “incompatible” for the reprocessing methods sterrad and steris.
  • Action
    Olympus is advising: "To ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the STERRAD and STERIS sterilisation methods, as such the IFU has been updated to change the compatibility to “incompatible” for the reprocessing methods STERRAD and STERIS". Users should inspect inventory for affected product and visually inspect the device prior to use as outlined in the IFU (section 5.1). If users are reprocessing devices using the STERRAD or STERIS, please discontinue and change to using one of the compatible reprocessing methods. An updated IFU to reflect this will be provided to users.

Device

HF-Resection Electrode
  • Modèle / numéro de série
    HF-Resection ElectrodeItem Numbers: A6280, A6281, A6282, A6283, A6284, A6289, A6292, A6293, A6294, A6299ARTG Number: 146187(Olympus Australia - Electrosurgical system, general-purpose)
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd