Events

Alerta De Seguridad para Name: KIT STIMULATING KNIFE RECOMMENDED WITH STIMULATING PROBE NIM RESPONSE Technical Name: ENDOTRACHEAL / ELECTRODE CODE Registration Number ANVISA: 10173550046 Hazard Class: II Model Affected: M8229306K, M8229307K, M8229308K

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Richards do Brasil Produtos Cirúrgicos Ltda.; MEDTRONIC XOMED 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
    2190
  • Fecha
    2017-02-10
  • 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
    ° Do not over-bend the EMG tube, especially at an acute angle (less than 90 °). Over-folding may cause the wire electrodes to exit the tube, piercing the cuff and exposing them. This can result in serious injury in which the exposed wire can penetrate the wall of the trachea or a vocal cord, or cause the cuff to empty, which will necessitate reintubation of the patient.
  • Causa
    In the last two years, the manufacturer has received reports of the endotracheal cannulae, in which the ends of the electrode wires, at the distal end of the cannula, have extruded through the cannula wall, entering the cuff and / or piercing the cuff and becoming exposed. four (4) of these complaints involved serious injuries in which an extruded / protruding electrode wire penetrated the tracheal wall or vocal cord (3 reports in china); or caused cuff disinflation and required patient reintubation (1 us report).
  • Acción
    Field Action Code FA713 II triggered under the responsibility of the company RICHARDS DO BRASIL PRODUTOS CIRÚRGICOS LTDA. Company will give guidance to health professionals.

Device

Name: KIT STIMULATING KNIFE RECOMMENDED WITH STIMULATING PROBE NIM RESPONSE Technical Name: ENDOT...

Manufacturer

Richards do Brasil Produtos Cirúrgicos Ltda.; MEDTRONIC XOMED INC
  • Source
    ANVSANVISA