Events

Rappel de Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Olympus 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-2013-RN-00680-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-11
  • 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-2013-RN-00680-1
  • 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
    Olympus has received a small number of reports where the pump may be supplied with the pump head in the unlocked position. if the pump head is unlocked, this may cause the pump to stop and go into stand-by mode. as a result, no water will be delivered to the endoscope.
  • Action
    Olympus are requesting users to discontinue use of the affected devices. An Olympus Field Service Technician will perform an inspection and modification if required. Olympus is also providing inspection and modification instructions should the end user wish to correct the device. At the time of agreement 17 customers had received the correction. These customers have been provided with the product correction information for their records.

Device

Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)
  • Modèle / numéro de série
    Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)Multiple Lot Numbers affected.ARTG Number: 145859
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd