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 064 05 16 000
  • Fecha de inicio del evento
    2016-05-11
  • 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=9339
  • 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
    Intuitive surgical identified particulate during quality inspections of the insufflation stopcock on the da vinci xi 5 mm-8 mm universal seal. the particulate has the potential to be introduced into the cannula lumen when insufflation is connected. although there have been no injuries identified related to this issue, we are initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart. during abdominopelvic and thoracic surgery, if the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (hdpe) particulate, its small size and the benign particulate geometry.

Device

da Vinci Xi Universal Seal
  • Modelo / Serial
    da Vinci Xi 5 mm-8 mm Universal Seal (PN 470361-05 and 470361-06) and da Vinci Xi 12 mm & Stapler Universal Seal (PN 470380-05 and 470380-06)
  • Descripción del producto
    Surgical Endoscope Instrument Control System
  • 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