Events

Rappel de THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)

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-2013-RN-01240-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-26
  • 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-2013-RN-01240-1
  • 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 has received complaints of damage to the thunderbeat hand instruments during surgical procedures.These complaints involve the following or a combination of the following descriptions:- cracking and deforming of the thunderbeat probe tip/jaw- partial separation of the ptfe (teflon) pad- exposed metal part due to severe wear of the ptfe padprobe damage detected during surgery will trigger audible and visual generator alarms.
  • Action
    Olympus Australia is providing additional user instructions on procedural techniques to prevent damage to the Thunderbeat hand instruments.

Device

THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)
  • Modèle / numéro de série
    THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries) Multiple Models affectedARTG Number: 209954
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd