Events

Alerta De Seguridad para Surgical instrument, telemanipulation, Minimally Invasive Surgery. Model PN 400042-01da Vinci Surgical Robots

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil 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
    271
  • Fecha
    2002-01-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Ecri received an account of a member of the system on the electric scalpel blade, which broke during two cardiac surgeries, using the above mentioned apparatus. the blades were left inside the chest cavity and were not recovered. even with malfunction of the device, no injury occurred in the patient. the manufacturer, who is aware of this problem, has done an investigation to determine the cause. he found a situation similar to that described, surgeons are often using an instrument to shave or clean another, causing displacement in the instrument of the unit.
  • Acción
    The manufacturer asks to advise surgeons that they should not use an instrument to clean another when the Da Vinci Robot is being used (running). He also provided further instructions and training for surgeons who use the system for the purpose of alerting and underlining this case. Intuitive Surgical has created a new insertion tool, which makes it difficult to drop the blade out of the instrument. The manufacturer claims that this modification has reduced the number of adverse events. For more information or if you have not received the new instructions, training and / or insertion tool, please contact Surgical at 1 (650) 237-7000.

Device

Surgical instrument, telemanipulation, Minimally Invasive Surgery. Model PN 400042-01da Vinci Sur...

Manufacturer

Intuitive Surgical Inc
  • Source
    ANVSANVISA