Events

Rappel de HF-Resection Electrodes Monopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope IFU version: W7074650_03

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-00863-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-07-14
  • 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-00863-1
  • 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
    Olympus has updated the instructions for use (ifu) for the hf resection electrodes. the ifu has been updated to include new contraindications, warnings and safety information.
  • Action
    Olympus is asking customers to: 1. Inspect inventory and replace any existing IFUs supplied with the device as per the list on Appendix A with the latest version provided in the customer letter; 2. Ensure all personnel are trained and/or familiarised themselves with the added contraindications, warnings and safety information as stated. Do not hesitate to contact your local Olympus Sales Specialist to organise additional training; 3. Complete the supplied reply form as per the instructions given; 4. If you have distributed or transferred any of the affected items from your facility to another, please forward this recall notice and also please notify Olympus so that we can follow up with that facility directly; 5. If you require additional hard/electronic copies of the IFU, please email RA@Olympus.com.au; and 6. If you have any queries or concerns in relation to this matter please do not hesitate to contact Olympus Customer Operations on 1300 657 699 or email RA@Olympus.com.au.

Device

HF-Resection Electrodes Monopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope I...
  • Modèle / numéro de série
    HF-Resection ElectrodesMonopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope IFU version: W7074650_03Multiple Item NumbersARTG Numbers: 146187 and 218223
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd