Events

Alerta De Seguridad O Notificaciones De Seguridad para Endoscope storage and drying cabinets

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por AFOS Ltd.

¿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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2007/035
  • Número del evento
    CON2031039
  • Fecha
    2007-05-10
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031039
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    The outer sheath and light guide tube of flexible endoscopes may be damaged by prolonged exposure to ultraviolet (uv) light used in these endoscope storage and drying cabinets. afos (nse) ltd has informed the mhra that some endoscope storage and drying cabinets have been fitted with a non-standard programme that allows the uv light to be switched on for eight hours a day instead of the expected 15 minutes every six hours. the mhra has received a report of significant deterioration to a flexible endoscope that was stored in an afos cabinet fitted with an incorrect programme. this type of damage to the outer sheath of the flexible endoscope insertion tube and light guide tube may: cause trauma to the patient; affect the functionality of the scope; allow ingress of fluids into the endoscope; inhibit effective decontamination of the endoscope by allowing micro-organisms to be retained in the damaged area of the endoscope; reduce the number of endoscopes available for use in the unit whilst the affected endoscope is being repaired.
  • Acción
    Check all flexible endoscopes that have been stored in AFOS endoscope storage facilities for damage. If the endoscope is damaged do not use it until it has been repaired. Contact AFOS to ensure that the endoscope storage and drying cabinet has the correct programme for UV light exposure. Do not use the storage and drying cabinet if it has the incorrect programme fitted. If no other suitable storage and drying cabinet is available carry out a risk assessment for the continued use of these cabinets for storing endoscopes. Be aware of MHRA advice given in MDA/2007/034.

Device

Endoscope storage and drying cabinets
  • Modelo / Serial
  • Descripción del producto
    Endoscope storage and drying cabinets: all endoscope storage facilities (ESF) manufactured by AFOS (NSE) Ltd.
  • Manufacturer
    AFOS Ltd

Manufacturer

AFOS Ltd