Events

Safety Alert for Patient Browser and Content Manager. Anvisa Registry n ° 80042070025.

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
    1732
  • Date
    2015-11-16
  • 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
    If a reference data sequence is deselected and the error persists, the magnitude of the offset or distortion will vary depending on the differences between the two data sequences. In some cases the displacement or distortion will be clearly visible when the plan is used in a Brainlab planning or navigation system. However, an offset may also not be so obvious. If a displacement or distortion occurs and is not detected during data review, diverting the information displayed in Brainlab's planning or navigation software may have a negative impact on a patient's clinical decisions. No negative effect on patients related to this problem has been reported to Brainlab by any customer to date.
  • Reason
    By actively deselecting a merged reference data stream in content manager (the default setting is "selected"), a point, an object, or a path may appear to be offset and / or distorted in the brainlab navigation or planning software that is used subsequently.
  • Action
    Field correction (software update). Recommendations for product users: Do not deselect individual data streams where a Point, an Object, or a Trajectory is planned. If you are unsure about the data sequence in which the Point, Object, or Trajectory was planned, do not deselect any of the contents of the plan. Instead, open the whole plane. Before beginning treatment of the patient, always check the plausibility of all the information inputs and outputs of the device. Company code for the field action: CAPA-20150804-001474. Access and read the warning message published by the manufacturer, available at: http://portal.anvisa.gov.br/wps/wcm/connect/df7295804a9dfab290a4b7218f91a449/Seguran%C3%A7a+em+Campo_1732.pdf ? MOD = AJPERES

Device

Patient Browser and Content Manager. Anvisa Registry n ° 80042070025.

Manufacturer

Brainlab Ltda; Brainlab AG
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    ANVSANVISA