Events

Retiro De Equipo (Recall) de VIDEO TELESCOPE

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
    130043
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-02-22
  • 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 initiated this recall after discovering that the endoeye distal end can become abnormally hot if the temperature sensor at the device's tip is damaged. although no customer complaints have been received referring to this issue and thus manufacturer is not aware of any patient or user injury excessive heating of the endoeye distal end could result in patient or user injury. to prevent a potential risk to patient or user health olympus is undertaking this action to repair the devices by disabling a specific feature on the video telescopes ("fog-free function") to prevent excessive heating of the endoeye distal end under certain conditions.

Device

VIDEO TELESCOPE
  • Modelo / Serial
    Model Catalog: WA50042A (Lot serial: >10 lot numbers contact mfg); Model Catalog: WA50040A (Lot serial: >10 lot numbers contact mfg)
  • Descripción del producto
    VIDEO TELESCOPE
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

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