Events

Retiro De Equipo (Recall) de CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator

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-2013-RN-01300-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-10
  • 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-01300-1
  • 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 notified by the manufacturer that there may be the potential that the blue coag button on the cusa excel cem nosecone could stick in the 'activated' position. a small number of complaints where this has occurred have been reported and of those, a smaller number resulted in tissue burn.
  • Acción
    Integra is providing an Update to the Instructions for Use (IFU). Integra is advising users to replace nosecone if the COAG button is observed to be sticking and contact Integra. Integra is advising users to check the nosecone during setup and prior to patient use and replace nosecone if observed to be sticking. If the Nosecone is to be used in excess of approximately 30 minutes during surgery, Integra is advising to replace the nosecone after 30 minutes of activation.

Device

CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
  • Modelo / Serial
    CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic AspiratorCatalogue Numbers: C6623 and C6636Lot Numbers: All lotsARTG Number: 197945
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd