Events

Rappel de Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste management system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker 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-00265-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-05-30
  • 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-00265-1
  • 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
    Further to the 'recall for product correction' undertaken in june 2012 (tga recall ref. # rc-2012-rn-00561-3) stryker in the usa received two reports of serious injury or death in procedures where neptune 2 was connected to a passive chest drainage tube or closed wound drainage device post-operatively. as a result of the additional reported adverse events, stryker is requiring additional actions to be implemented in order to continue to use the neptune device(s).
  • Action
    Stryker will arrange for a warning label and placard to be added to each Neptune device. Stryker is asking hospitals to ensure that all users of the Neptune device, including surgeons, surgical residents and health profession students are adequately trained, and are aware of the risks associated with the device. Education training is also provided in the form of a web based presentation for all Neptune Users. Training can be accessed via www.strykerwastemanagement.com.au using Login: neptune Password: stryker. A DVD will be made available as a further alternative for continued and ongoing training.

Device

Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste ma...
  • Modèle / numéro de série
    Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste management system)Neptune 2 Rover Ultra Catalogue Number: 0702-002-000All Serial NumbersNeptune Bronze RoverCatalogue Number: 0700-007-000All Serial NumbersARTG Number: 164275
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA