Events

Rappel de Fujifilm ED-530XT 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 Fujifilm 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-00034-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-11
  • 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-00034-2
  • 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 operation manuals have been revised to reflect newly validated manual cleaning and high-level disinfection procedures. this action is being taken as a result of reports of multi-drug resistant bacteria on endoscopesused for endoscopic retrograde cholangiopancreatogram (ercp) procedures. revisions have been made to the ed-530xt operation manuals, “preparation and operation” and “cleaning, disinfection and storage.” these revisions modify the cleaning and disinfection processes and require the use of a new disposable distal end cleaning brush to be used for the cleaning of the duodenoscope’s distal tip, forceps elevator and elevator recess, in addition to use of the existing fujifilm valve cylinder cleaning brush.
  • Action
    FujiFilm is providing users with updated instructions manuals and samples of the new disposable distal end cleaning brush. All previous versions of the IFU should be discarded. This action has been closed-out on 01/03/2018.

Device

Fujifilm ED-530XT Duodenoscope
  • Modèle / numéro de série
    Fujifilm ED-530XT Duodenoscope Serial Numbers: MD102A129, MD102A130ARTG Number: 139172
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd