Events

Notificaciones De Seguridad De Campo acerca de OLYMPUS TJF‐145 DUODENOSCOPE

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 xx is writing to inform you that we are issuing validated, new reprocessing instructions for the olympus tjf‐145 duodenoscope, consisting of revised manual cleaning and disinfection procedures to increase the safety margin against infection after ercp using the tjf‐145. these new reprocessing procedures should be implemented as soon as possible. the new cleaning procedure requires the use of a new cleaning brush (maj‐1534), which is enclosed with this letter. after the enclosed brushes are consumed, the brushes will be available for purchase in sufficient quantities to meet your facility’s needs through our normal sales order process. please note the maj‐1534 brush is a reusable brush, which can be sterilized by autoclave following use. instructions for sterilizing the maj‐1534 brush can be found in the enclosed, new reprocessing manual. .

Device

OLYMPUS TJF‐145 DUODENOSCOPE
  • Modelo / Serial
  • Manufacturer
    Olympus

Manufacturer

Olympus