Events

Rappel de Pentax PTX-EG-387UTK Ultrasound Video Gastroscope (flexible gastroduodenoscope)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2012-RN-00819-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-13
  • 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-2012-RN-00819-3
  • 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
    Pentax has been notified of a potential risk related to the use of the eg-3870utk ultrasound video gastroscope in combination with aspiration needles if the instructions for use is not followed carefully by the user. specifically, if the user fails to properly position the elevator while advancing the aspiration needle through the endoscope, the needle could disengage from the elevator.
  • Action
    Customers are being provided with revised instructions for use (IFU) which should be read and followed by the users of the equipment. The owners manual is to be updated with the addendum that has been provided by the Sponsor.

Device

Pentax PTX-EG-387UTK Ultrasound Video Gastroscope (flexible gastroduodenoscope)

Manufacturer

Device Technologies Australia Pty Ltd