Events

Rappel de EVOTECH Endoscope Cleaner and Reprocessor (ECR)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2013-RN-01344-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-19
  • 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-2013-RN-01344-1
  • 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
    The pentax eg-3670urk flexible endoscope has been qualified for use with the evotech ecr, however it cannot currently be processed in the evotech ecr due to incorrect flow rate parameter programming in the system that is specific to this endoscope. the minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of low flow.
  • Action
    Johnson & Johnson Medical is advising users with the Pentax EG-3670URK scope to manually clean and undertake a high level of disinfection prior to use. The EVOTECH ECR can continue to be used in accordance with the user guide for all other endoscopes that have been qualified and validated. A software update will be implemented as a permanent fix.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR)

Manufacturer

Johnson & Johnson Medical Pty Ltd