Alerta De Seguridad para RESOLUTION CLIP DEVICE - Registered in Anvisa under the number 10341350360 - M00522610 - Lot: 0ML9042702 - Boston Scientific do Brasil.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific do Brasil Ltda..

¿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
    973
  • Fecha
    2009-07-30
  • 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
    We are aware that hospitals often remove the products from their outer packaging and store them on hospital shelves, only in their internal pouches. If this is a practice in your unit, it is very important that you carefully use the table below and consider both the internal code and the external code of the product packaging when searching for affected products of this voluntary recall, since UPN Codes on the labels of the inner packagings of the product are different from those on the outer packagings. The product information listed on your specific Verification and Traceability Response Form (which is attached to this alert). Source: Boston Scientific. ### Update on 11/09/2009 - The company informed Anvisa of the closure of the action for the collection of the affected products through file 749932 / 09-9 dated 10/01/2009.
  • Causa
    It was identified during a manufacturer's inspection and testing process that the torque conductor used to insert the set of screws that connect the control wire to a cross pin of the resolution® clips device was out of calibration. this may result in an inability to position or release catheter.
  • Acción
    The actions recommended to product users are as follows: (1) Immediate discontinuation of use and segregation of the affected product in this alert. (2) Complete and return the verification and traceability response form to: Boston Scientific of Brazil - A / C: Carolina Yin - Fax: (11) 5502-8510 or e-mail: yinc@bsci.com.

Manufacturer