Events

Alerta De Seguridad para System for Use in Procedures of Image Guided Surgery

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Medtronic Navigation Inc. || Cfi Medical Solutions || Medtronic Navigation, Inc. || Northen Digital Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1705-172
  • Número del evento
    2013DM-0010390
  • Fecha
    2017-05-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that the referenced devices have been rigorously tested and are designed for use only with medtronic instruments, their use with other types of instruments has not been validated or tested, this practice could lead to serious adverse events on the patient.

Device

System for Use in Procedures of Image Guided Surgery
  • Modelo / Serial
  • Descripción del producto
    Both software and instruments and accessories are for exclusive use with MEDEDONIC's computer-assisted surgery system which is indicated for use in neurosurgery, spinal, orthopedic (hip, knee) and ENT (ear, nose) procedures. and throat). The system allows the exact location of anatomical structures and planning surgical trajectories in open and percutaneous interventions.
  • Manufacturer
    Medtronic Navigation Inc. || Cfi Medical Solutions || Medtronic Navigation, Inc. || Northen Digital Inc

Manufacturer

Medtronic Navigation Inc. || Cfi Medical Solutions || Medtronic Navigation, Inc. || Northen Digit...
  • Source
    NIDFSINVIMA