Events

Notificaciones De Seguridad De Campo acerca de OLYMPUS ENDOEYE HD II Video Telescope

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 has initiated this removal action following a complaint of a damaged temperature sensor at the endoeye tip which caused the distal end to become abnormally hot. although no patient or user injury occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury. in an effort to prevent a potential risk to patient or user health, olympus is undertaking this action to remove the model and serial numbers identified above and to repair and return the devices. the repair to correct this problem will not be available until january 2016. however, we are requiring the return of your affected devices now so as to disable a feature on the video telescopes (“fog free”) which will prevent excessive heating of the endoeye distal end. once the repair parts are available in january 2016, we will contact you again for return of your devices for the permanent corrective action. .

Device

OLYMPUS ENDOEYE HD II Video Telescope
  • Modelo / Serial
    WA50040A, WA50042A
  • Manufacturer
    OLYMPUS

Manufacturer

OLYMPUS