Events

Safety Alert for SURGICAL / CLINICAL PLANNING SOFTWARE IPLAN BRAINLAB. Anvisa Registration n ° 80042070008.

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
    1275
  • Date
    2013-07-26
  • 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
    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.
  • Reason
    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.
  • Action
    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.

Device

SURGICAL / CLINICAL PLANNING SOFTWARE IPLAN BRAINLAB. Anvisa Registration n ° 80042070008.

Manufacturer

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