Alerta De Seguridad para Trade name: Bridge. Technical Name: Cystouretroscope Bridge. ANVISA registration number: 80124630089. Risk class: II. Affected Model: A20976A / A20977A. Serial numbers affected: A20976A - 152W, 155W, 14XW A20977A - 155W, 156W, 158W, 16ZW.

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 Winter & Ibe Gmbh.

¿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
    2370
  • Fecha
    2017-08-25
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    From now on, all cistouretroscope bridges will be delivered without adhesive. This does not affect the passage of the instrument. An external laboratory validation has demonstrated that the devices can be successfully reprocessed and their adhesive within the working channel. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. 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 Additional information: - Date of identification of the problem by the company: 07/24/2017 - Date of notification notice to Anvisa: 08/25/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    The manufacturer olympus winter & ibe gmbh has received complaints about adhesive fragments that have stood out from within the working channel of the cited cystouretroscope bridge models. cracking, fragmentation, missing pieces and delamination of the adhesive were observed. in one case, a fragment of the adhesive was detected within the patient's urethra during a procedure and was removed without causing injury. investigations have confirmed that this adhesive may become detached during the intended use and / or reprocessing of the cystourethoscope bridges cited.
  • Acción
    Field Action Code FA_150_01 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. It will perform an affected unit change.

Manufacturer