Events

Notificaciones De Seguridad De Campo acerca de OLYMPUS ENDOEYE HD II

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por OLYMPUS.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Olympus started this [vka / removal procedure] when they found that the distal end of the endoeye could become extremely hot if the temperature sensor at the tip of the device was damaged.   even though we have not received any complaint from this [customer] about this issue - meaning no injury to the patient or user - overheating the distal end of the endoeye may cause injury to the patient or user. we strive to prevent potential patient or user health risks, and we therefore take olympus to [recall / remove] the model and serial numbers listed above, as well as modify and return devices.

Device

OLYMPUS ENDOEYE HD II
  • Modelo / Serial
  • Manufacturer
    OLYMPUS

Manufacturer

OLYMPUS