Events

Notificaciones De Seguridad De Campo acerca de ECHO-HD-22-EBUS-O, ECHO-HD-25-EBUS-O

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 Cook Medical Europe.

¿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
  • Fecha
    2015-11-25
  • 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
    Cook ireland ltd is in the process of updating its ifu0051 instruction manual (ifu0051) from revision 5 to revision 6 to enter text concerning the endobronchial ultrasound needle of the echotip® ultra-high resolution, “this product is for single use only. any attempt at recovery, sterilization and / or reuse may result in product failure and / or transfer diseases, as the aforementioned text was omitted in revision 5 of these operating instructions. this statement was included in a previous revision of the package leaflet and is intended for customers who have not previously received a product and are therefore not aware of the risks of reusing this product as required by mdd 93/42 / ec.

Device

ECHO-HD-22-EBUS-O, ECHO-HD-25-EBUS-O

Manufacturer

Cook Medical Europe