Events

Alerta De Seguridad para SURGICAL NAVIGATION SOFTWARE FOR SKULL / ORL. Anvisa Registry n ° 80042070022.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BRAINLAB LTDA.; BRAINLAB AG.

¿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
    1639
  • Fecha
    2015-07-23
  • 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
    The following factors may have a significant effect on the overall navigation accuracy of the device: (1) Large distance between the reference star and the region of interest; (2) Large changes in camera positioning relative to the reference star during the procedure. Such occurrences may intensify small inaccuracies resulting from specific steps of the complex navigation procedure. In the worst case scenario, such inaccuracies may result in inaccurate display of the instruments by the navigation system, compared to the actual anatomy of the patient. Brainlab has released a new version of Brainlab Cranial software (version 2.1.2) to fix the problem. Until the new software is installed, users of the product should follow the instructions already provided by the company "Measures to Improve the Precision of Skull Navigation" and read the warning message issued by the company for this field action.
  • Causa
    Certain occurrences may intensify inaccuracies in the system, which may result in inaccurate display of the instruments by the navigation system compared to the actual anatomy of the patient.
  • Acción
    Software update.

Device

SURGICAL NAVIGATION SOFTWARE FOR SKULL / ORL. Anvisa Registry n ° 80042070022.

Manufacturer

BRAINLAB LTDA.; BRAINLAB AG
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    ANVSANVISA