Events

Recall of Neptune 2 Rovers(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-2015-RN-00555-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-06-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00555-1
  • 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
    It has been identified during the installation of neptune rovers that there is a potential for the rover’s diverter valve assembly to not actuate during docking, preventing the cleaning cycle from occurring and inhibiting prefill water from being supplied to the neptune fresh water system. the diverter valve’s material combined with the heat-treating process has the potential to cause diverter valve corrosion when the rover is allowed to sit for a period of greater than 40 days.Only neptune 2 rovers out of rotation for greater than 40 days have the potential of exhibiting the failure. there is no risk to health as the neptune rover will be unable to dock either during installation or prior to surgery. rovers that are in active rotation are not likely to experience any issue related to this diverter valve material issue.
  • Action
    A Stryker Representative will contact affected facilities who have indicated they have Rovers which have not been used for over 40 days to schedule time to perform the diverter valve replacement. This action has been closed-out on 03/03/2016.

Device

Neptune 2 Rovers(Mobile unit used as surgical fluid/smoke waste management system)
  • Model / Serial
    Neptune 2 Rovers(Mobile unit used as surgical fluid/smoke waste management system)Catalogue Number: 0702-001-000Serial Numbers ranging from 0803118093 through 505400223Distribution or Repair Dates: 1 Nov 2011 to 31 Mar 2015ARTG Number: 164275
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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