Events

Rappel de TJF-Q180V Duodenoscope

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-00098-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-27
  • 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-00098-1
  • 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 received reports of patient infections associated with the elevator sealing mechanism of the tjf-q180v duodenoscope. olympus is updating the existing tjf-q180v operation manual, the tjf-q180v reprocessing manual and will perform a correction to the forceps elevator mechanism. this is further to the urgent recall for product correction notification issued in june 2015 (tga ref: rc-2015-rn-00475-1).
  • Action
    Affected units can continued to be used, provided the leakage test as outlined in the revised Reprocessing Manual is performed before every use. Olympus is providing instructions for users to access the updated Operation and Reprocessing Manual. Olympus is undertaking a correction of all affected TFJ-Q180V elevator mechanisms and will provide users with loan units whilst the units are being repaired. This action has been closed-out on 27/02/2017.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd