Events

Retiro De Equipo (Recall) de Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-2017-RN-01276-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-11
  • 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-2017-RN-01276-1
  • 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
    Integra neurosciences has been advised that certain lots of footswitch supplied with the cusa clarity console may be faulty.A faulty footswitch may result in unintended ultrasonic fragmentation activation. there are two scenarios during which the failure mode may occur:1. ultrasonic fragmentation may be activated after set-up is complete and the user goes to the main screen (without the footswitch pressed); and/or2. ultrasonic fragmentation may remain activated during surgical use once the footswitch amplitude pedal is disengaged.There have been no adverse events or injury reported.
  • Acción
    Integra is advising users to quarantine the affected units from use. Affected units will be replaced with unaffected stock.

Device

Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000
  • Modelo / Serial
    Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000Catalogue Number: C7002Lot Numbers: 1885744, 1923802, 1985221, 2057996, 2109587 and 2118507ARTG Number: 283158
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd