Alerta De Seguridad para Trade name: OSCILANTE SAW ADAPTER, FOR REF. 532.001 E 532.010 Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number: 80145901733 Hazard Class: I Affected Model: SYNTHES ROTATIONAL NON-CUTTING INSTRUMENTAL Affected Series Numbers: SKU: 532.021 || Lot: All Serial Numbers

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes 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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    If you have any of the affected products identified, follow these steps: • Perform inspection as documented in Document 1 (page 5). This inspection step should be part of the entire reprocessing cycle. • If you notice that the connecting piece has disassembled, or if you can not unscrew the part, do not use the product and send it immediately for repair. • Devices that perform satisfactorily during inspection, as described in Document 1, do not need to be returned for repair and may be used as indicated. We will implement a review and repair, if necessary, during your next scheduled maintenance inspection at your designated Synthes Service Center. • Ensure that devices are shipped for maintenance according to the recommended annual schedule. • Ensure that all persons at your facility, who may be involved in this notification, read this letter carefully. • Keep a copy of this notice with the affected product (s) listed above. • Complete the Verification Section (page 4 of this letter), marking the appropriate field to indicate that the affected product was located and inspected. In addition, indicate which inspected serial numbers are acceptable and which must be returned for service. Enter your name, title, address, phone number and signature in the spaces provided. • Return the completed Verification Section to your local DePuy Synthes contact. • To arrange for the technical assistance of the devices, contact your local DePuy Synthes sales organization.
  • Causa
    It has been reported that the oscillating saw connection part may loosen during surgery.
  • Acción
    Field Action Code R2014068 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.