Events

Alerta De Seguridad para motor for orthopedic surgery

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 Stryker Instruments || Stryker Ireland-Instruments.

¿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
    R1502-70
  • Número del evento
    2008DM-0002802
  • Fecha
    2015-02-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 laser welder could have failed in the continuous line union for the housings referenced, this fault in the welding could lead to the separation of the two housings sections causing the loss of mechanical connection between the handpiece and the battery, leading to generate possible adverse events on the patient and the prolongation of surgical time.

Device

motor for orthopedic surgery
  • Modelo / Serial
    SYSTEM 6, model 6126-120-000, lots 13205, 13209, 13210 and 13212.
  • Descripción del producto
    These equipments are destined to generate the controlled movement of its accessories and associated instruments in order to facilitate orthopedic procedures by means of power, speed in circular, rotating and oscillating movements controlled among others for efficient cuts and perforations in bone as well as for the placement and extraction of the materialatornillable of the osteosynthesis material.
  • Manufacturer
    Stryker Instruments || Stryker Ireland-Instruments

Manufacturer

Stryker Instruments || Stryker Ireland-Instruments
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NIDFSINVIMA