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-2015-RN-00432-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-05-22
  • 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-00432-1
  • 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 evotech endoscope cleaner and reprocessor (ecr) may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. the likelihood of this occurrence is low, and asp has not received complaints or reports of adverse events related to this issue.The evotech ecr is designed to verify endoscope connections for each cycle. if an improper connection is detected, the system is designed to stop and cancel the cycle. this system detection, along with a user verification step stated in the user’s guide to verify the connections of the endoscope channels before and after the completion of a cycle, help to ensure that an endoscope has been processed properly.As a result sites may need to manually process endoscopes which may increase processing time. an accumulation of processing time may result in surgical delay or rescheduling patients.
  • Action
    A workaround is provided via the Customer Letter whilst a permanent fix is developed. This action has been closed-out on 03/03/2016.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR)
  • Modèle / numéro de série
    EVOTECH Endoscope Cleaner and Reprocessor (ECR)Part numbers: 50004 and 50004-002ARTG number: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd