Events

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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00265-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00265-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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).
  • Acción
    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...
  • Modelo / 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
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA