Events

Safety Alert Or Field Safety Notices for Endoscope storage and drying cabinets

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by AFOS Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/035
  • Event Number
    CON2031039
  • Date
    2007-05-10
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031039
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    Endoscope storage and drying cabinets: all endoscope storage facilities (ESF) manufactured by AFOS (NSE) Ltd.
  • Manufacturer
    AFOS Ltd

Manufacturer

AFOS Ltd