Events

Rappel de HF Cable used with ESG-400 Electrosurgical Generator (bipolar)

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-2016-RN-01161-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-09-07
  • 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-2016-RN-01161-1
  • 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 is notifying users of the reoccurrence of potential error codes for the olympus wa00014a hf cable. although procedures can continue by troubleshooting and clearing error codes in accordance with the esg-400 instructions for use (section 8.2), olympus is highlighting instances of the following error codes when the device is connected: - e618 ‘data transfer’, - e486 ‘no instrument connected’; or, - a pop up message ‘use default instrument settings’ there have been no australian reports of these error codes or incidents with patient injury worldwide. error codes typically only occur in the rare event of rapid activation, such as re-activating the esg-400 electrosurgical generator within 0.2 seconds after the last activation.
  • Action
    Olympus is advising users that if the error occurs, to troubleshoot as per the Instructions for Use (IFU) to continue the procedure, and notify Olympus to obtain a replacement cable. This action has been closed-out on 12/05/2017.

Device

HF Cable used with ESG-400 Electrosurgical Generator (bipolar)
  • Modèle / numéro de série
    HF Cable used with ESG-400 Electrosurgical Generator (bipolar)Product Code: WA00014A ARTG Number: 194874
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd