Events

Rappel de GF-UCT180 Ultrasonic Gastrovideoscope

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-2015-RN-00909-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-11
  • 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-2015-RN-00909-1
  • 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 nature of this product correction is to issue a revised instruction for use (ifu) which includes instructions on how to correctly clean the device. there is a risk of patient-to-patient infection if the device is not cleaned appropriately. key changes in the new instruction for use are highlighted below:· inclusion of instruction on how to attach the cleaning adapter (maj-350) to the instrument channel port of the gf-uct180· the balloon applicator (maj-675) and the cleaning brush (maj-1534) are to be reprocessed for reuse. the maj-675 and maj-1534 are to be reprocessed in accordance with step “cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment”.
  • Action
    Olympus is advising their customers of the amendments to the IFU. Customers can request a new IFU by contacting Olympus. Hospitals are advised that a review of internal hospital protocols should be conducted to ensure compliance with the updated cleaning instructions. This action has been closed-out on 29/08/2016.

Device

GF-UCT180 Ultrasonic Gastrovideoscope
  • Modèle / numéro de série
    GF-UCT180 Ultrasonic GastrovideoscopeARTG Number: 145874
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd