Events

Alerta De Seguridad para Engines for Surgical Use

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por 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
    R1602-78
  • Número del evento
    2008DM-0003014
  • Fecha
    2016-02-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected that the charger has a component that can fail prematurely due to manufacturing failure, if the component fails, the firmware of the charger recognizes the malfunction and prevents the batteries from charging, the blue led on the front of the charger flashes to indicate that the device should be sent for repair, leading to potential adverse events on patients or delays in surgical times.

Device

Engines for Surgical Use
  • Modelo / Serial
    UNIVERSAL BATTERY CHARGER II (UBC II), references 05.001.204, lots 10615 to 12616.
  • Descripción del producto
    The engines for surgical use are tools that are intended to generate a continuous movement of their accessories that are cutting tools such as drills, bits and saws in orthopedic and traumatology procedures such as: placement and extraction of prosthesis and osteosynthesis material, intramedullary milling, traumatology in general, foot and hand surgery, surgery, maxillofacial neurosurgery and vertebral surgery
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh