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-2015-RN-00475-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-06-03
  • 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-2015-RN-00475-1
  • 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 australia is issuing revised manual cleaning and high level disinfection procedures for the tjf-q180v duodenoscope. users are not required to return any devices to olympus.Further to olympus’ safety alert notification issued in march 2015, the manufacturer has since issued new reprocessing procedures applicable to the tjf-q180v duodenoscope. key changes in the new reprocessing procedures are:-- inclusion of a new single use brush (maj-1888), for cleaning around the forceps elevator- increase the number of raising/lowering of the forceps elevator and flushing of the elevator recess during pre-cleaning and manual cleaning.Ancillary cleaning items (single use soft brushes and a new reprocessing manual) have been sent to the relevant endoscopy units pertaining to this recall for product correction.
  • Action
    Users are asked to implement the new reprocessing procedures for the TJF-Q180V and to ensure that all personnel involved in the reprocessing are knowledgeable and thoroughly trained on the new procedures. This action has been closed-out on 13/10/2016.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd