Events

Retiro De Equipo (Recall) de ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CONMED CANADA.

¿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
    22904
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-02-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Conmed canada is sending this reminder to provide important information concerning the proper use of altrus thermal tissue fusion handpieces. the reason for this notification is to reinforce best practices when using energy devices. energy based vessel sealing devices are vital in the continued improvement in surgical approaches. as with all energy based technologies there are risks. it is important to follow the defined instructions for use when handling these devices after they are activated. use caution and best practices as these devices generate heat. ensure the jaws of your energy based vessel sealing devices are not in contact with unintended tissue surfaces or objects until the jaws have cooled sufficiently. if the jaws are still hot there is a risk that a patient could be unintentionally burned if they have not cooled sufficiently. always refer to a device's operator's manual and instructions for use for proper use and warnings.

Device

ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Modelo / Serial
    Model Catalog: 60-9511-001 (Lot serial: All Lots); Model Catalog: 60-9512-001 (Lot serial: All Lots); Model Catalog: 60-9520-001 (Lot serial: All Lots); Model Catalog: 60-9521-001 (Lot serial: All Lots); Model Catalog: 60-9522-001 (Lot serial: All Lots); Model Catalog: 60-9510-001 (Lot serial: All Lots)
  • Descripción del producto
    ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    HC