Events

Safety Alert Or Field Safety Notices for Flexible endoscopes

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 Olympus.

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/2007/034
  • Event Number
    CON2031041
  • 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/CON2031041
  • 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 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.
  • Action
    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
  • Model / Serial
  • Product Description
    Flexible endoscopes manufactured by Olympus, distributed in the UK by KeyMed Limited.
  • Manufacturer
    Olympus

Manufacturer

Olympus