Events

Retiro De Equipo (Recall) de ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode)

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-2014-RN-00522-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-09
  • 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-00522-1
  • 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 advised they have received complaints that the electrode gel may make contact with an internal staple causing no output, sparking and heat build-up between the staple and the electrode foil contact surface. whilst there have been no complaints and no reports of injury or death received by the product sponsor in australia, one patient in japan was reported to have received a skin tear.
  • Acción
    ConMed is requesting their customer to immediately discontinue the use of the device and arrange for its return. This action has been closed-out on 29/01/2016.

Device

ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode)

Manufacturer

ConMed Linvatec Australia Pty Ltd