Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Richards do Brasil Produtos Cirúrgicos Ltda.; MEDTRONIC XOMED INC.

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
    2190
  • Date
    2017-02-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    ° 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.
  • Reason
    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).
  • Action
    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