Events

Retiro De Equipo (Recall) de CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConMed Linvatec 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-2016-RN-01129-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-08-26
  • 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-2016-RN-01129-1
  • 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
    The manufacturer has received complaints of damage to the electrode shaft insulation, which could increase the risk of a patient burn.To date, conmed has not received any reports where this has led to illness or injury.
  • Acción
    ConMed Linvatec is advising users to immediately discontinue use of the affected product and to return it to ConMed Linvatec for credit or replacement. This action has been closed-out on 10/05/2017.

Device

CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode ...
  • Modelo / Serial
    CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels)Reference/Catalogue Number: CS-023Affected Lots: 267221 to 695063ARTG Number: 94017
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd