Events

Alerte De Sécurité sur SURGICAL / CLINICAL PLANNING SOFTWARE IPLAN BRAINLAB. Anvisa Registration n ° 80042070008.

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; Brainlab 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
    1275
  • Date
    2013-07-26
  • 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
    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.
  • Cause
    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
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    ANVSANVISA