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
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 has determined that there is a potential risk to the hummingbird adapter and the small adapter for colibri ii, as well as to the battery unit and the small drive ii battery, by generating excessive internal pressure that may cause the respective products to burst, leading to present possible adverse events on patients or users.


  • Modelo / Serial
    Hummingbird Adapter and the Battery Unit, reference 05.001.108, serial 1215.
  • 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, craniomaxillofacial surgery, neurosurgery and spinal surgery
  • Manufacturer