Events

Retiro De Equipo (Recall) de THUNDERBEAT FRONT-ACTUATED GRIP

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

¿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
    66535
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-10-04
  • 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
    Olympus has received customer complaints on the deterioration of the thunderbeat probe during surgical procedures. these complaints involve a combination of the following descriptions - the generation of audible and visual generator alarms the deformation of the components of the thunderbeat probe tip or jaw or the detaching of a fragment from the thunderbeat probe tip or jaw. olympus has investigated these complaints and the manufacturer has determined that improvements to the labeling for surgical technique including recommendations for best practices in cutting and dissection techniques during laparoscopic hysterectomy are appropriate to reduce/eliminate these complaints associated with device use.

Device

THUNDERBEAT FRONT-ACTUATED GRIP
  • Modelo / Serial
    Model Catalog: TB-0545FC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0535FC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0545PC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0535PC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0510IC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0535IC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0520IC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0545IC (Lot serial: > 10 numbers contact mfg.)
  • Descripción del producto
    THUNDERBEAT FRONT-ACTUATED GRIP
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    HC