Events

Alerta De Seguridad O Notificaciones De Seguridad para Flexible endoscopes

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 Olympus.

¿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/2007/034
  • Número del evento
    CON2031041
  • 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/CON2031041
  • 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 olympus flexible endoscopes may be damaged by direct exposure to ultraviolet (uv) light, as used in some endoscope storage and drying cabinets. keymed has informed the mhra of the increase in olympus flexible endoscopes being returned to them for repair due to damage to the outer sheath of the insertion tube and light guide tube. olympus believes that this damage is caused by prolonged exposure to uv light, as used in some endoscope storage and drying cabinets and causes significant deterioration in the outer coating of all olympus flexible endoscopes. 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 endoscope 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
    Avoid placing Olympus flexible endoscopes in storage and drying cabinets where UV light shines directly onto the endoscope. If no other suitable storage or drying cabinet is available carry out a risk assessment for the continued use of these cabinets for storing and drying Olympus flexible endoscopes. Before purchasing a new endoscope ensure that it is compatible with local endoscope storage and drying cabinets. Be aware of MHRA advice given in MDA/2007/035.

Device

Flexible endoscopes
  • Modelo / Serial
  • Descripción del producto
    Flexible endoscopes manufactured by Olympus, distributed in the UK by KeyMed Limited.
  • Manufacturer
    Olympus

Manufacturer

Olympus