Events

Alerta De Seguridad para Estech surgical stabilization platform 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 Endoscopic Technologies, Inc..

¿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
    A1501-34
  • Número del evento
    2012DM-0009204
  • Fecha
    2015-01-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=187
  • 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 states that if the instructions for use (ifu) for the above systems are not followed, the stainless steel cable may break during use, a situation that may arise with the repositioning of the cable when it is tensioned, or when an excessive adjustment is made, and by corrosion when using a cleaning solution inadequately during decontamination, which can lead to potentially adverse events occurring on the patient.

Device

Estech surgical stabilization platform system
  • Modelo / Serial
    HERCULES 3 / 001-401-161 and HERCULES 360 / 001-401- 160, distributed since May 2011.
  • Descripción del producto
    Instruments for cardiovascular surgical interventions used in heart surgery. They are specifically designed to provide stabilization, positioning, arterial isolation and cleaning of tissues or structures, improving visibility during surgery.
  • Manufacturer
    Endoscopic Technologies, Inc.

Manufacturer

Endoscopic Technologies, Inc.
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    NIDFSINVIMA