BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EGD SCOPE

    MDR report key: 8371983 · Received February 26, 2019

    Report

    Report Number
    MW5084400
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    February 13, 2019
    Report Date
    February 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MILD BUCKLING IDENTIFIED INSIDE THE CONTROL BODY WHERE THE INSERTION TUBE BOOT ATTACHES TO THE GRIP. ALL EGD SCOPES IN THIS ORGANIZATION WERE REVIEWED AS A PRECAUTIONARY MEASURE AFTER SEVERE FOLDING WAS FOUND IN THE WORKING CHANNEL OF ONE OLYMPUS EGD SCOPE. SCOPE WAS SENT TO MANUFACTURER FOR REPAIR 02.14.2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165679 OLYMPUS EGD SCOPE GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDS OLYMPUS MEDICAL SYSTEM CORPORATION GIF H180

    Patients

    Seq Age Sex Outcome Treatment
    1