Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BRAINLAB LTDA.; BRAINLAB AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1639
  • Date
    2015-07-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    Software update.

Device

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

Manufacturer

BRAINLAB LTDA.; BRAINLAB AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA