BEUDAMED
    FDA Adverse Event Other Summary report: N

    US ELITE SYSTEM CYSTOURETHROSCOPE SHEATH

    MDR report key: 2163596 · Received June 6, 2011

    Report

    Report Number
    1519132-2011-00016
    Event Type
    Other
    Date Received
    June 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FBO
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INSTRUMENTS FINDS THE SHEATH TO BE BENT AND THE DISTAL END OF THE TUBE TO BE DENTED. THE VERY DISTAL TIP HAS NUMEROUS NICKS AND DENTS BUT NO SIGN OF MISSING MATERIAL, BURRS OR LOOSE METAL ON THE INSIDE OR OUTSIDE OF TUBE. THE METAL TIP OF THE OBTURATOR IS SMOOTH AND SHOWS NO SIGNS OF ANY MISSING MATERIAL. THE OBTURATOR IS CATCHING INSIDE THE SHEATH AND DRAGGING DUE TO THE SHEATH BEING BENT. THE BEND PROFILE IN THE SHEATH TUBE SUGGESTS APPLICATION OF LATERAL FORCE WAS EXERTED ON THE INSTRUMENT BY THE USER. WITH THE INSTRUMENTS BEING 15 YEARS OLD, BOTH SHOW NORMAL WEAR AND TEAR.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE US ELITE SYSTEM CYSTOURETHROSCOPE SHEATH THE SURGEON NOTICED THAT THE METAL WAS FLAKING OFF IN THE BLADDER. THE PIECES WERE WASHED AWAY WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 US ELITE SYSTEM CYSTOURETHROSCOPE SHEATH CYSTOURETHROSCOPE SHEATH FBO GYRUS ACMI, INC. E121

    Patients

    Seq Age Sex Outcome Treatment
    1