Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Intuitive Surgical Inc.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 029 12 15 000
  • Fecha de inicio del evento
    2015-12-09
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8594
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Upon becoming aware of publ ications identifying a risk of capacitive coupling from monopolar energy sources to endoscopes in laparoscopic surgery, intuitive surgical initiated an investigation to determine if this risk applies to existing da vinci technologies. as a result of this investigation, intuitive surgical has identified specific configurations in which monopolar energy has the potential to be transmitted fro m the da vinci xi endoscope shaft to tissue it is contacting.

Device

da Vinci® Xi™ endoscope and cannulae configurations
  • Modelo / Serial
    Product Name : 8mm Endoscope, 0° Part Number : 470026-34, 470026-40, 470026-41 Product Name : 8mm Endoscope, 30° Part Number : 470027-34, 470027-40, 470027-41
  • Descripción del producto
    endoscopes
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc
  • Empresa matriz del fabricante (2017)
    Intuitive Surgical Inc
  • Representante del fabricante
    Gulf Medical Co, Jeddah (012)6512828
  • Source
    SFDA