Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00265-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00265-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA