Events

Alerte Ou Avis De Sécurité sur Flexible endoscopes

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 Olympus.

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/2007/034
  • Numéro de l'événement
    CON2031041
  • 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/CON2031041
  • 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 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
  • Modèle / numéro de série
  • Description du dispositif
    Flexible endoscopes manufactured by Olympus, distributed in the UK by KeyMed Limited.
  • Manufacturer
    Olympus

Manufacturer

Olympus