Events

Rappel de Pentax ED-3490TK Video 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 Hoya Lens 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-00238-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-07
  • 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-00238-1
  • 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
    Pentax is issuing updated, validated manual reprocessing instructions for the ed-3490tk video duodenoscope to replace those provided in the original device labelling. the updated reprocessing instructions for the ed-3490tk video duodenoscope include a more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilisation procedures. in addition, updated instructions include additional text, figures, cautions and warnings intended to clarify the validated reprocessing procedure.If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection.
  • Action
    Pentax is providing affected customers with updated Instructions for Use intended to clarify the validated reprocessing procedure. This action has been closed-out on 27/01/2017.

Device

Pentax ED-3490TK Video Duodenoscope

Manufacturer

Hoya Lens Australia Pty Ltd
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    DHTGA