Events

Alerte De Sécurité sur Bronchoscope FN-53A, Larynx-Fibro Pediatric FN-40A and flexible endoscopes.

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 HUGER ENDOSCOPY INSTRUMENTS CO., LTD; Brazilian Endoscope Industria e Comercio de Equipamentos Medicos Ltda./ENDOBRAX.

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
    1278
  • Date
    2013-07-02
  • 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
    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.
  • Cause
    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