Events

Safety Alert for KOLIBRI STEREOTECH SYSTEM. Anvisa Registry n ° 80042070005.

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

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
    1027
  • Date
    2010-09-01
  • 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
    After conducting a risk assessment of the problem, the company concluded that it is a critical severity problem whose probability of occurrence is remote. According to the company, in Brazil there are 9 units of equipment under risk.
  • Reason
    Attaching the camcorder to the cradle is unreliable due to a manufacturing error. during use, the camera (weighing approximately 3 kg) may detach itself from the stand and fall, which may result in a serious adverse event to the patient or user.
  • Action
    Users / health care professionals should regularly check the camera unit before attaching or transporting the equipment to the mounting screws. To do this, proceed as follows: (1) Close all wheel locks on the equipment support; (2) Place the camera arm in the 90 ° (horizontal) position until it snaps into place; (3) Hold the camera by rotating it about its vertical axis until it reaches the limit; (4) Apply moderate force in the horizontal and vertical direction of the camera unit - there should be no movement between the camera and its interface. More detailed information can be found at http://portal.anvisa.gov.br/wps/wcm/connect/8553ee8043cfc47f9399934eca73f154/Carta+to+Product.pdf?MOD=AJPERES. The registration holder has already initiated the communication with the users of the product and informed that he will correct the products at risk.

Device

KOLIBRI STEREOTECH SYSTEM. Anvisa Registry n ° 80042070005.

Manufacturer

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