Alerta De Seguridad para Product trade name: ROBÓTICO SURGICAL SYSTEM DA VINCI - INTUITIVE SURGICAL /// Record number: 10302860146 /// Affected lots: SG378; SH2360; SH2344; SG664; SH2065; SH1528; SH2341; SH1153; SH1866; SH2200; SH2362; SH2339; SH2273; SH2338; SH2312; SH2274; SH2078; SH1527 / / / Product hazard class: III.

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 LTD.; 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
    1954
  • Fecha
    2016-04-26
  • 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
    Recommendations for users and patients: To manipulate a cardiac ablation catheter, use only the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
  • Causa
    The company clarifies that "microscopic metal particles may be generated during intracardiac surgery, both robotic and non-robotic. use of other da vinci instruments other than the heart probe hold device (e.G., the large needle driver) to manipulate a cardiac cryoablation probe during da vinci heart surgery has been shown to increase the amount of microscopic metal particles. the purpose of this communication is to inform that only the heart probe hold device should be used to manipulate a cryoablation probe in cardiac procedures. ".
  • Acción
    Risk classification: III /// Field action classification: Update and complementation of the Instructions for use /// Field action code: TECNOVIGI / AC / 02-2016 /// Recommendations to users and patients: To manipulate a probe only use the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.

Manufacturer