Events

Alerta De Seguridad para Endodontic Endodontic System II - Endoprosthesis System Technical Name: Vascular Endoprosthesis ANVISA Registration Number: 10339190330/10339190508 Hazard Class: IV Model Affected: ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C145EE; ENBF2516C170EE; ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C166E; ETBF2313C166EE; ETBF2316C124EE; ETBF2316C145EE; ETBF2316C166E; ETBF2316C166EE; ETBF2513C124EE; ETBF2513C145EE; ETBF2513C166EE; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C166E; ETBF2516C166EE.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA; MEDTRONIC IRELAND; MEDTRONIC MEXICO; MEDTRONIC INC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2214
  • Fecha
    2017-03-02
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    There is no action required for patients already implanted, since the potential for incorrect classification of endoleak by variation of permeability occurs acutely in the implant. Patients who received implants from the 23 mm or 25 mm Endurant / Endurant II Bent Endotracheal System Implanted by this recall do not require any additional monitoring because of this action and should continue to be monitored in accordance with their standard practice. #### UPDATED ON 7/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the client and collection of the equipment informed.
  • Causa
    Medtronic is initiating a voluntary recall of a subset of the endurant / endurant ii bifurcated endoprosthesis systems of models (see appendix a) and specific serial numbers. this specific subset of endoprostheses is more susceptible to variations in permeability that may be associated with endoleaks observed during the initial implant procedure. at the time of the implant procedure, this variation of permeability may cause the physician to characterize a type iv endoleak (which usually resolves over time) as an acute type iii tissue endoleak, as the leak may appear to be focal or localized leakage as opposed to diffuse leakage (redness). incorrect classification as an acute type iii tissue endoleak may lead to unnecessary secondary interventions.
  • Acción
    Field Action Code FA758 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will collect.

Device

Endodontic Endodontic System II - Endoprosthesis System Technical Name: Vascular Endoprosthesis A...

Manufacturer

MEDTRONIC COMERCIAL LTDA; MEDTRONIC IRELAND; MEDTRONIC MEXICO; MEDTRONIC INC
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA