Events

Retiro De Equipo (Recall) de Neptune 2 Rovers(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-2015-RN-00555-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-06-30
  • 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-2015-RN-00555-1
  • 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
    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.
  • Acción
    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)
  • Modelo / 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
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA