Events

Retiro De Equipo (Recall) de SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)

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-00574-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-29
  • 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-00574-1
  • 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
    Stryker has been made aware of a spike in the occurrence of tip breaks identified for the 90r probe. the investigation triggered by same confirmed the shape and location of the tip break in each case to be the same. in each event a small piece from the distal end of the alumina ceramic broke off. the geometry of this type of crack differs from those normally observed by serfas probes.
  • Acción
    Customers are asked to check any SERFAS 90° Energy Probe items in their possession and quarantine any affected units immediately . A Stryker Representative will coordinate an inspection of your affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued. This action has been closed-out on 08/08/2016.

Device

SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)
  • Modelo / Serial
    SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)Item Number: 279-350-101Affected Lots: 13128AE2 to 14337AE2ARTG Number: 146512
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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