Events

Alerta De Seguridad para Scalpel System

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 Ethicon Endosurgery Inc || Ethicon Endosurgery S.A. De C.V. || Ethicon Endosurgery Llc.

¿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
    I1803-198
  • Número del evento
    2012DM-0008445
  • Fecha
    2018-03-22
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=51
  • 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

Device

Scalpel System
  • Modelo / Serial
    GEN11, all serials.
  • Descripción del producto
    The scalpel system is indicated for soft tissue incisions, when a control of the hemorrhage and a minimal thermal injury is desired. The system can be used as an assistant or substitute for electrosurgery, laser and steel scalpel, in general interventions, pediatric plastic, gynecological, exposure to orthopedic structures, open and endoscopic interventions. Approve to extend the indication, for the reference HARMONIC FOCUS CURVED SHEARS to otolaryngological processes (ORL), thus: the curved scissors HARMONIC FOCUS are indicated for soft tissue incisions when you want to control the bleeding and minimal thermal injuries. The instruments can be used as a complement or substitute for electrosurgery, laser and scalpel in general, otorhinolaryngological structures (ENT), aesthetic, pediatric, gynecological, urological, exposure to orthopedic structures (such as spinal cord and joint space) and other open procedures.
  • Manufacturer
    Ethicon Endosurgery Inc || Ethicon Endosurgery S.A. De C.V. || Ethicon Endosurgery Llc

Manufacturer

Ethicon Endosurgery Inc || Ethicon Endosurgery S.A. De C.V. || Ethicon Endosurgery Llc