Events

Rappel de ED-530TK 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-2018-RN-00146-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-27
  • 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-2018-RN-00146-1
  • 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
    In response to recent concerns regarding the ability to thoroughly clean duodenoscopes, fujifilm has redesigned some components of the ed-530xt duodenoscope. corrective actions for the ed-530xt include replacement of the forceps elevator mechanism and o-ring seal, replacement of the distal end cap, and new operation manual. the updated design, maintenance schedule and labelling have all been implemented to help reduce any potential risk to health that may be associated with inadequate reprocessing of the device.Fujifilm, through the distributor c.R. kennedy & co, will provide a revised operation manual to be followed. below is the main update to the operation manual:- added the requirement for the ed-530xt to be returned to local fujifilm dealer or authorised service representative for inspection and replacement of the forceps elevator seal once a year to maintain safe use of the device.
  • Action
    FujiFilm is advising users to review and update the handling and re-processing procedures. Affected products will be serviced to replace the affected parts.

Device

ED-530TK Duodenoscope
  • Modèle / numéro de série
    ED-530TK DuodenoscopeSerial Numbers: MD102A129, MD102A130, 1D102K227, 1D102K388, 1D102K394, 1D102K436, 1D102K460, D102K508, 1D102K517ARTG Number: 139172(Fujifilm Australia - Duodenoscope, flexible, video - Dudoenoscope, flexible, video)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd