Alerta De Seguridad para SURGICAL / CLINICAL PLANNING SOFTWARE IPLAN BRAINLAB. Anvisa Registration n ° 80042070008.

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
    1275
  • Fecha
    2013-07-26
  • 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
    Brainlab Ltda reported that if the potentially incorrect format of the object is not detected by the user during the revision of the imported plane, and the object is used in surgery performed with the aid of a navigation system from Brainlab, the information may potentially induce the surgeon to error, ultimately resulting in ineffective treatment, severe injury, or even death of the patient. Refer to the appendix of the enclosed document "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" for detailed instructions on User Corrective Actions. Users should always follow the instructions and warnings as described in the iPlan User Manuals, in particular: "The appearance and visualization may be different between Brainlab applications (eg planning and navigation software) due to to different user interfaces and workflows. Exported data should always be scanned on the target platform before a surgery. " In addition, it is of great importance to read the FIELD SAFETY NOTICE / PRODUCT NOTIFICATION disclosed by the company, which details the failure conditions and the actions required by the user to reduce the risk until the update available from Brainlab.
  • Causa
    Under certain conditions, when exporting a treatment plan created with brainlab iplan 3.0 for use with the brainlab navigation software, planned objects may not be displayed correctly in the navigation software.
  • Acción
    To the users of the equipment: read carefully and follow the recommendations of the company disclosed in the letter WARNING OF FIELD SAFETY / NOTIFICATION OF PRODUCT, available in http://portal.anvisa.gov.br/wps/wcm/connect/48255a00407f1318b6acb647eaaaed7e/Aviso_de_Seanca. pdf? MOD = AJPERES. BRAINLAB has already begun communicating the problem to its customers and will carry out a software update to correct the problem, which is scheduled to be completed by July 2014.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA