Events

Alerta De Seguridad para da Vinci endoscopic instrument control system

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 Intuitive Surgical, 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
    I1802-117
  • Número del evento
    2016EBC-0014795
  • Fecha
    2018-02-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=55
  • 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

Device

da Vinci endoscopic instrument control system
  • Modelo / Serial
    DA VINCI XI, serial SK0954
  • Descripción del producto
    The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVE SURGICAL endoscopic instruments during urological surgical procedures, laparoscopic general surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures. The system can also be used with adjunctive mediastinotomy to perform coronary artery bypass during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon's console, a patient's car and a vision car, it also includes ENDOWRIST endoscopes and instruments.
  • Manufacturer
    Intuitive Surgical, Inc

Manufacturer

Intuitive Surgical, Inc