Events

Notificaciones De Seguridad De Campo acerca de Cook Multi-Use Holmium Laser Fibers

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
  • 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 medical is initiating a voluntary correction of the products listed above. we have identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. our preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. there have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization associated with these devices. potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. .

Device

Cook Multi-Use Holmium Laser Fibers

Manufacturer

Cook Medical Europe