Alerta De Seguridad para Product name: VINCI ROBOTIC SURGICAL SYSTEM - INTUITIVE SURGICAL /// ANVISA registry number: 10302860146 /// Risk class: III /// Affected model (s): Da Vinci Surgical System and Surgical System Vinci Xi, but in Brazil there is only the commercialization of the da Vinci model Si.///Affected serial number (s): All series numbers manufactured until November 2015, but in Brazil we only have the following numbers of series: SH2344; SH2341; SH2362; SH2312; SH2339; SH2360; SH2338; SH2361.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por H. Strattner & Cia LTDA.; 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
    1863
  • Fecha
    2016-04-06
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
  • Causa
    "it has been reported that the flash memory cards used in the touchpad on the patient arm carriage and on the surgeon's console can corrupt the data if the system has a sudden drop in power or is turned off and reconnected within a short period of time. time. in some cases, the failures can be recovered, but in others the same will not be possible, preventing the use of the system. ".
  • Acción
    a) Risk classification: III /// b) Classification of the field action: Field correction by voluntary replacement of the non-compliant component, without need of disclosure in large vehicles /// c) Field action code: TECNOVIGI / AC / 01-2016 /// d) Recommendations to users and patients: This Field Action aims to inform customers about the possible occurrence of a malfunction of a component of the equipment and to perform the component exchange, voluntarily. It has been reported that the memory cards used in the touchpad may corrupt if the system has a sudden drop in power or is turned off and reconnected within a short period of time. In some cases, the failures can be recovered, but in others the same will not be possible, preventing the use of the system. In case of an error on the touchpad, proceed as standard

Manufacturer