Events

Alerta De Seguridad para Ureterorenofibroscope Technical Name: Ureterorenofibroscope Registration Number ANVISA: 80124630193 Hazard Class: II Model Affected: URF-P6 / P6R Series Affected: 2613119,2613237,2613239,2612933,2612936,2612947,2112H189,2613101, 2612937, 2613240, 2613102,2613844,2613861,2613846,2613847,2613848,2613845,2613864,2613866.

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.; 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
    2201
  • Fecha
    2017-02-15
  • 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 of instructions for safe use of the equipment to mitigate all risks.
  • Causa
    Olympus medical systems corporation received customer complaints regarding the use of urf-v2 / v2r (not registered in brazil) there were reported 4 adverse events reported in the following countries: france / usa / canada / japan, all urf- v2 / v2r. due to the great similarity with the product urf-p6 / p6r (registered in brazil), it was determined that action was also for this model. the root cause was associated with rupture of the flexible tip, a rupture associated with unsafe use in the patient.
  • Acción
    Field Action Code FA_148_05 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Ureterorenofibroscope Technical Name: Ureterorenofibroscope Registration Number ANVISA: 801246301...

Manufacturer

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