Events

Alerte De Sécurité sur M3 MULTIMEDIA MICRO COLLECTOR. Anvisa Registry n ° 80042070017.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Brainlab Ltda; Brailab AG.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1201
  • Date
    2012-11-16
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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 .

Device

M3 MULTIMEDIA MICRO COLLECTOR. Anvisa Registry n ° 80042070017.

Manufacturer

Brainlab Ltda; Brailab AG
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    ANVSANVISA