BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-X / IMAGE 1 S

    MDR report key: 11973996 · Received June 10, 2021

    Report

    Report Number
    11973996
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 2, 2021
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLADDING PART OF THE URETEROSCOPE LOOSENED AND GOT DISPLACED BEYOND THE TIP OF THE SCOPE. IT FOLDED BACK ON ITSELF, THEREBY CAUSING AN INABILITY TO NATURALLY BE PULLED OUT OF THE URETER. THE SURGEON RESOLVED THE ISSUE BY MOVING THE URETEROSCOPE FURTHER INTO THE SPACE TO RE-STRAIGHTEN THE CLADDING. WITH THIS ACTION, HE WAS ABLE TO WITHDRAW THE SCOPE WITHOUT ANY HARM TO THE PATIENT. THE EVENT HAPPENED WHEN THE SURGEON WAS READY TO PULL OUT THE SCOPE, AFTER IT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869254 FLEX-X / IMAGE 1 S URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB KARL STORZ GMBH & CO. KG 11278VSUA

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA