Events

Rappel de Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)

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-2013-RN-01044-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-10-14
  • 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-01044-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, intuitive surgical inc, is informing customers that the incorrect version of the user manual associated with the single-site instruments, specifically the bipolar maryland and curved needle driver instruments, was not distributed to customers prior to shipment and use of the instruments.
  • Action
    Device Technologies is notifying their customers of the issue. A Device Technologies representative will contact each customer to organise the delivery of the correct User Manual. Customers are requested to discard the previous version once the new User Manual has been received. This action has been closed-out on 10/02/2016.

Device

Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device wi...
  • Modèle / numéro de série
    Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)Single-Site Bipolar MarylandProduct Code: INS-428080Single-Site Curved Needle DriveProduct Code: INS-428088ARTG Number: 132453, 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd