Events

Alerta De Seguridad para Trocar KII Access Systems

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 Applied Medical Resources.

¿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
    R1706-214
  • Número del evento
    2008DM-0003058
  • Fecha
    2017-06-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=83
  • 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 the referenced devices may have compromised their sterility, leading to the potential occurrence of adverse events on patients.

Device

Trocar KII Access Systems
  • Modelo / Serial
  • Descripción del producto
    The trocar KII access systems are indicated in laparoscopic interventions of general, abdominal, gynecological and thoracic minimally invasive surgery, with the purpose of establishing an insertion path or achieving access through tissue planes and / or potential spaces for endoscopic instruments. All components are made of latex-free materials. The trocar access systems are sterile and disposable devices for use in a single patient. Optical trocar access systems use an optical element to visualize the tissue layers during insertion; however, they can be used without visualization for primary or secondary inserts.
  • Manufacturer
    Applied Medical Resources

Manufacturer

Applied Medical Resources