Events

Safety Alert for Bronchoscope FN-53A, Larynx-Fibro Pediatric FN-40A and flexible endoscopes.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by HUGER ENDOSCOPY INSTRUMENTS CO., LTD; Brazilian Endoscope Industria e Comercio de Equipamentos Medicos Ltda./ENDOBRAX.

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
    1278
  • Date
    2013-07-02
  • 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
    The Technovigilance Unit will be monitoring and evaluating the effectiveness of the collection of the products./////// UPDATE - 08/13/2014 - Published Resolution - RE n. 3,047 dated August 12, 2014. DOU n ° 154, of 08/13/2014, considering the contents of the Investigation Report of the Superintendency of Sanitary Surveillance of the State of Minas Gerais, whose findings detected a typo when the Brazilian company Endoscope Indústria e Comércio de Equipamentos Médicos Ltda./ENDOBRAX (CNPJ: 07.427.470 / 0001-85), causing incorrect coding and, therefore, the lack of a registration number in the electronic system of this Agency. The company corrected the typo on its website, as documented in the mentioned report.
  • Reason
    Marketing of health products without registration./////// update - 08/13/2014 - the superintendency of sanitary surveillance of the state of minas gerais issued a research report stating that a typo was identified when developing the electronic site of the company brazilian endoscope indústria e comércio de equipamentos médicos ltda./endobrax, causing incorrect coding and, therefore, the lack of a registration number in the electronic system of this agency. the error has already been fixed.
  • Action
    To determine, as a measure of health interest, the suspension of the importation, distribution, disclosure, trade and use of the FN-40A Bronchoscope, Fibro Laringo-Bronco Pediatric FN-40A products and flexible endoscopes, as well as collection of the products specified above. // UPDATE - 08/13/2014 - Repeal of Resolution RE No. 2.286, of July 1, 2013. DOU n ° 125, of 07/02/2013., Through Resolution - RE n. 3,047 of August 12, 2014. DOU No. 154, of 08/13/2014.

Device

Bronchoscope FN-53A, Larynx-Fibro Pediatric FN-40A and flexible endoscopes.

Manufacturer

HUGER ENDOSCOPY INSTRUMENTS CO., LTD; Brazilian Endoscope Industria e Comercio de Equipamentos Me...
  • Source
    ANVSANVISA