Events

Alerta De Seguridad para Duodenoscope Technical Name: Duodenoscope ANVISA Registration Number: 80124630021 Hazard Class: II Affected Model: TJF-145 / TJF-150

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
    2310
  • Fecha
    2017-06-05
  • 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 reprocessing and cleaning guidelines until they receive the new manual versions and the new MAJ-1534 cleaning brush.
  • Causa
    Olympus optical of brazil received a notification from olympus corporation of the americas regarding a voluntary global field action initiated by olympus medical systems corporation for the above referenced products. faced with the mitigation of client infection following procedures with the tjf-145 / tjf-150 duodenoscopes, olympus decided to increase the safety margin, review the reprocessing manual and include a new cleaning brush in the method.
  • Acción
    Field Action Code FA_149_01 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Duodenoscope Technical Name: Duodenoscope ANVISA Registration Number: 80124630021 Hazard Class: I...

Manufacturer

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