Events

Rappel de Monopolar HF Resection Electrodes

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-2017-RN-00498-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-20
  • 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-2017-RN-00498-1
  • 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 has received an increased number of complaints regarding loop wires breaking at the distal end of the electrodes. investigations have confirmed that loop wires can break during the intended use of the electrodes. as a result, a fragment may fall inside the patient and will need to be retrieved. under certain circumstances, the retrieval could require additional surgical treatment. to date, no reports of adverse events or patient injuries have been received by olympus.
  • Action
    Olympus is requesting users to inspect their inventory and quarantine the affected lots. Affected products are to be returned for replacement.

Device

Monopolar HF Resection Electrodes
  • Modèle / numéro de série
    Monopolar HF Resection ElectrodesModel Number: A22201CLot Numbers: 16123P03L001, 16139P03L001, 16144P03L001, 16173P03L001, 16174P03L001, 16210P03L001, P16X0001, P16X0002, P16Y0001 and P16Y0003Model Number: WA22037CLot Number: P16Y0001ARTG Number: 218223
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd