Events

Rappel de Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope

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-01519-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-19
  • 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-01519-1
  • 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
    Omsc has received a small number of adverse event reports globally for the urf-v2 associated with damage to the bending section. to date, no adverse events have been reported to olympus in australia for the urf-v2 and no adverse events reported globally for the urf-p6. further to olympus’ safety alert issued in december 2016 (rc-2016-rn-01653-1), the manufacturer has modified the design of the bending section of the urf-v2 and urf-p6 to address any deficiencies that may have attributed to the adverse events reported globally.
  • Action
    Olympus is advising hospitals to identify affected devices from their inventory. When replacement URF-V2 and URV-P6 devices are available, an Olympus Customer Operations Specialist will contact users to exchange devices at affected facilities. In the interim, users may refer to the IFU and Safety Alert issued by Olympus for the correct inspection and use of the device.

Device

Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope
  • Modèle / numéro de série
    Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope Model Numbers: URF-V2 and URF-P6ARTG Numbers: 211118 and 131068
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd