Events

Alerta De Seguridad para Videoduodenoscope, Brand: Olympus, Record: 80124630021, Serial numbers: SEE ANNEX.

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 Corporation..

¿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
    1538
  • Fecha
    2015-03-11
  • 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
    According to the company, there are no cases reported in Brazil of infection associated with the use of this endoscope and no indication of changes in levels of safety and efficacy of the product. The alert has the preventive character.
  • Causa
    Alert about the association of duodenoscope use and presence of infection after performing the procedure with this equipment. the complaints that have arisen are of occurrences located in the united states. the reported infections are caused by carbapenen-resistant enterobacteria (ckd) in which drug treatment is limited to few antibiotics.
  • Acción
    The registrant guides reprocessing of the endoscope through high-level disinfection and the process must be performed according to the manufacturer's recommendations. Failure to follow pre-cleaning instructions, leak testing, manual cleaning and disinfection or sterilization has the potential of cross-contamination and risk of infection. The orientation is for customers to ensure that the reprocessing team is aware and trained to perform the procedures in accordance with the instructions in the manual. In addition, the team is advised to inspect the equipment before use by evaluating the presence of stains or improper cleaning and, in such cases, re-reprocessing. It is important to report the occurrence of cases of infection and persistent bacterial colonization associated with the use of the Olympus endoscope. Any other guidance or training request the company is available to contact.

Device

Videoduodenoscope, Brand: Olympus, Record: 80124630021, Serial numbers: SEE ANNEX.

Manufacturer

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