Events

Rappel de OER-AW Endoscope Reprocessor

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-00130-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-01-30
  • 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-00130-1
  • 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
    There is an update of the operation manual for the oer-aw endoscope reprocessor to instruct users of non-detachable distal cover type duodenoscopes, such as the tjf-q180v duodenoscope, to follow the pre-cleaning and manual cleaning as stated in the duodenoscope’s reprocessing manual prior to setting them into the oer-aw.The following warning has been added to the list of compatible endoscopes/connecting tubes and chapter 4 “basic endoscope reprocessing operations” of the oer-aw operation manual - "when reprocessing the following non-detachable distal cover type duodenoscopes using oer-aw, conduct pre-cleaning and manual cleaning as detailed in each duodenoscope’s reprocessing manual".
  • Action
    Olympus is requesting users to inspect their inventory and replace any existing OER-AW Operation Manuals and List of Compatible Endoscopes/Connecting Tubes with the latest version supplied.They are further advised to implement the instructions enclosed in the updated OER-AW Operation Manual. This action has been closed-out on 06/07/2017.

Device

OER-AW Endoscope Reprocessor
  • Modèle / numéro de série
    OER-AW Endoscope ReprocessorImpacted models of duodenoscopes: JF-20, JF-140F, TJF-M20, TJF-30, TJF-145, TJF-140F, TJF-150, TJF-160F, TJF-160VF and TJF-Q180VARTG Number: 185051
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd