Events

Retiro De Equipo (Recall) de Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators

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-2014-RN-01079-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-09
  • 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-2014-RN-01079-1
  • 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 identified through an investigation of complaints that some specific lots of selector® tubing kits may potentially leak irrigation fluid during use if not placed on the selector handpiece in a specific manner. if the lumens of the 2 tubes are not separated before placing them on the handpiece barbs, this could result in an irrigation fluid leak. if the leakage is significant, the handpiece tip could overheat and possibly burn tissue being treated.
  • Acción
    Integra is providing additional instructions to prevent the occurrence of leakage. This action has been closed-out on 03/06/2016.

Device

Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators
  • Modelo / Serial
    Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators Catalogue number: 1517079Multiple lot numbersARTG number: 146847
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd