BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX X2 URETERO-RENO FIBERSCOPE

    MDR report key: 4892633 · Received July 2, 2015

    Report

    Report Number
    1221826-2015-00047
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FBO
    PMA / PMN Number
    K062918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SCOPE WAS MISSING A LASER WELD ON THE VERTEBRAS. THE LACK OF A WELD RESULTED IN THE VERTEBRAS SEPARATING FROM THE SLOTTED TUBE. WHEN THAT SEPARATION OCCURRED, THIS BROKE THROUGH THE SHEATHING, CAUSING THE BLUE DYMAX UV BOND MATERIAL TO BECOME TORN AWAY FROM THE TOP OF THE THREAD WRAP THAT GOES OVER THE ANGLE COVER.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A URETEROSCOPY WITH KIDNEY STONE REMOVAL, A PIECE OF RUBBER AT BENDING SECTION OF THE SCOPE BROKE OFF IN THE PATIENT. THE BROKEN PIECE WAS RETRIEVED WITH A STONE BASKET. ANOTHER FLEXIBLE URETEROSCOPE WAS USED. PROCEDURE WAS COMPLETED WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433095 FLEX X2 URETERO-RENO FIBERSCOPE FLEXIBLE URETEROSCOPE FBO KARL STORZ ENDOVISION 11278AU1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention