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
    I1611-522
  • Número del evento
    2016EBC-0014795 ; 2009DM0003498
  • Fecha
    2016-11-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=114
  • 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 incorrect use of the instrument and operating problems may cause insufficient seal, blade detachment and non-retraction of the system, which may lead to potential delays in surgical times and adverse events for the patient.

Device

da Vinci endoscopic instrument control system
  • Modelo / Serial
    IS4000-XI, IS3000-SI and SI-E, concerning the EndoWrist sealant, references 410322 and 480322.
  • Descripción del producto
    The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVESURGICAL endoscopic instruments during urological surgical procedures, general laparoscopic surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures . The system can also be used with adjoining mediastinotomy to perform coronary anastomosis 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 car and a vision car, it also includes the endoscopes and instrumentosendowrist.
  • Manufacturer
    Intuitive Surgical, Inc

Manufacturer

Intuitive Surgical, Inc