Events

Alerte Ou Avis De Sécurité sur Endoscope storage and drying cabinets

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par AFOS Ltd.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2007/035
  • Numéro de l'événement
    CON2031039
  • Date
    2007-05-10
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031039
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    Endoscope storage and drying cabinets: all endoscope storage facilities (ESF) manufactured by AFOS (NSE) Ltd.
  • Manufacturer
    AFOS Ltd

Manufacturer

AFOS Ltd