Events

Notificaciones De Seguridad De Campo acerca de Monopolar high-frequency resection electrodes

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 the implementation of the [field safety corrective action (fsca) / removal measure] for the above monopolar high-frequency resection electrodes. the electrodes are used for endoscopic diagnostics and treatment in urology and gynecology.   olympus has taken this [safety corrective action / removal measure] because it has received a large number of complaints about loop breaks at the distal end of said electrodes. investigations have confirmed that the loops can actually break during the intended use of the electrodes. the loop particle can then fall into the patient and need to be removed. in certain cases, additional surgical treatment is required to remove this particle. in addition, this can prolong the procedure and, consequently, the duration of the anesthesia.

Device

Monopolar high-frequency resection electrodes
  • Modelo / Serial
  • Manufacturer
    Olympus

Manufacturer

Olympus