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-00046-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-17
  • 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-00046-1
  • 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 since 2009 they have received a small number of complaints for cusa tip breakage. the manufacturer's investigation of these complaints identified that when the tips are used under specific circumstances with the cem nosecone, there is the potential for erosion of the cusa tip. the erosion can potentially lead to tip breakage.Specifically, the potential for cusa tip erosion occurs only during cem operation and if the side of the tip, rather than the annulus of the tip, is in contact with the tissue.
  • Acción
    Integra Neurosciences Pty Ltd is revising the package insert to include an additional warning advising users to ensure that only the CEM Nosecone contacts the intended tissue at the annulus of the tip and not the side of the tip to avoid tip breakage.

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, C6636All lot numbers affectedARTG Number: 197945
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd