Events

Alerta De Seguridad para Trade name: VIDEODUODENOSCOPIO ###. Technical name: VIDEODUODENOSCOPIO ###. ANVISA registration number: 80124630021 ###. Risk class: II (Medium Risk) ###. Model Affected: TJF-160VF / TJF-160F ###. Affected Lot Numbers: 2802533, 2103207, 2103215, 2103214, 2802547, 2003129, 2103203, 2203242, 2303243, 2303244, 2103226, 2103221, 2103205, 2103209, 2103194, 2103202, 2500817, 2003172, 2802085, 2701664, 2802134, 2103199, 2302248 , 2701768, 2103208, 2701843, 2701851, 2003135, 2902744, 2902746, 2103223, 2701978, 2902846, 2902870, 2602725, 2802115, 2302325, 2902995, 2103200, 2003139, 2802551, 2902901, 2602730, 2802118, 2802281, 2602728, 2903001, 2103197 , 2103201, 2802590, 2802591, 2802592, 2902834, 2902835, 2802138, 2902787, 2902836, 2701791, 2701807.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Olympus Optical do Brasil Ltda. Rua do Rócio; Olympus Medical Systems Corp..

¿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
    1978
  • Fecha
    2016-08-15
  • 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
    The customer letter describes the actions that Olympus is taking for this field action and informs the customer that the equipment can be used normally in the meantime. It also informs customers that they will continue to follow current reprocessing and cleaning guidelines until they receive new versions of manuals. Warning: SEE ALSO TECNOVIGILANCE NO. 1829 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through System NOTIVISA. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Olympus received customer complaints for the tjf-160vf and tjf-160f duodenoscopes associated with infections in patients after performing endoscopic procedures. olympus decided to increase the safety margin for the tjf-160vf and tjf-160f. root causes for the problem: the exact causes have not been conclusively determined in many cases (infections can be caused by factors such as inappropriate use of automated endoscope scanners or disinfectants, inappropriate handling of reprocessed devices, etc.). improper reprocessing by users can not be excluded in some cases. no problems were found in the manufacturing process of the tjf-160vf and tjf-160f.
  • Acción
    Field Action Nº FA_148_04 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company is performing Safety Alert and providing brushes to optimize product cleaning.

Device

Trade name: VIDEODUODENOSCOPIO ###. Technical name: VIDEODUODENOSCOPIO ###. ANVISA registration n...

Manufacturer

Olympus Optical do Brasil Ltda. Rua do Rócio; Olympus Medical Systems Corp.