Safety Alert for M3 MULTIMEDIA MICRO COLLECTOR. Anvisa Registry n ° 80042070017.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Brainlab Ltda; Brailab 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
    1201
  • Date
    2012-11-16
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    According to the company Brainlab Ltda, treatment plans for the M3 MICRO MULTILINE COLLECTOR typically contain pairs of closed blades and ideally no dose should be administered through the small space remaining between the tips of the enclosed blades of the equipment. However, according to the company a small leak is technically unavoidable, unless this blade gap is covered by the linear accelerator collimator (primary collimators). Therefore, to avoid administering a dose to the patient with undesired radiation leakage, it is essential that the space between the pairs of closed blades of the M3 is always completely protected by the primary collimators of the linear accelerator. If the leaked dose exceeds the clinically desirable limits for a particular treatment plan, severe injury to the patient may result. According to the company, no adverse events related to the problem in question have been reported so far. Anvisa's Technovigilance Unit is monitoring this case.
  • Reason
    Possibility of a small leakage of radiation through the gap between the slides of the equipment, during the application of the therapy.
  • Action
    Brainlab said it had already communicated the clients involved about the problem by letter. The corrective action of the company consists of an update of the instructions of use of the equipment, alerting to the use of the equipment in its correct configuration. If you have the equipment in your inventory, make sure that the linear accelerator primary collimators always fully cover the clearance of the closed blades of the Multi-Collimator M3 Multi Collimator. Read also the alert message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7616c6004d79898d903ef1c116238c3b/16+de+novembro+Messagem+de+alerta.pdf?MOD=AJPERES .

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    ANVSANVISA