BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOSTAT FIBER

    MDR report key: 1591641 · Received January 28, 2010

    Report

    Report Number
    2937094-2010-00002
    Event Type
    Other
    Date Received
    January 28, 2010
    Report Date
    December 28, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K972575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURIES WERE REPORTED. THE FIBER WAS RETURNED FOR FAILURE ANALYSIS. THE FAILURE ANALYSIS CONSISTED OF A VISUAL INSPECTION UNDER 30X MAGNIFICATION AND TRANSMISSION OF LASER LIGHT THROUGH THE FIBER. PHOTOGRAPHS WERE TAKEN. ANALYSIS REVEALS THE EXISTING TIP OF THE FIBER IS NOT BURNED OR MELTED, BUT IS FRACTURED. THERE IS A SCORE MARK IN THE JACKET APPROX 0.180" FROM THE TIP OF THE FIBER INDICATING THERE WAS AN ATTEMPT TO STRIP AND CLEAVE THE FIBER TIP. AN UNSUCCESSFUL STRIP AND CLEAVE OF THE FIBER WILL CAUSE A PORTION OF THE FIBER JACKET TO BE STRETCHED OVER THE FIBER OUTPUT WHICH CAN RESULT IN DAMAGE TO THE FIBER OR POSSIBLY IGNITE WHEN SUBJECTED TO LASER ENERGY. AN UNSUCCESSFUL STRIP AND CLEAVE OF THE FIBER IS USUALLY AN INDICATION THE WRONG SIZE FIBER STRIPPER WAS USED. LABELING IS SUFFICIENT AND PROVIDES INSTRUCTIONS ON STRIPPING AND CLEAVING WITH WARNINGS: "NOTE: WHILE CLEAVING, IF YOU SLIP OFF THE TARGET AREA, STOP. SELECT A NEW AREA AT A LOCATION PROXIMAL TO THE LOCATION OF THE FAILED CLEAVE AND START SCORING/CLEAVING AGAIN. IT IS ESSENTIAL TO HAVE A GOOD SCORE TO OBTAIN A CLEAN BREAK. A POOR CLEAVE MAY CAUSE THE TIP TO FLARE." "A DULL STRIPPER CAN BE THE MOST LIKELY CAUSE OF A DISTAL TIP FLARE." "WARNING: ENSURE THERE IS NO FRAYED JACKET AT THE DISTAL END OF THE FIBER BEFORE USING. RE-CLEAVE AND STRIP AS NECESSARY. ENSURE THERE IS NO DEBRIS ON THE DISTAL TIP SURFACE. ENSURE THERE ARE NO CHIPS ON THE DISTAL TIP SURFACE. ANY CHIPS OR DEBRIS ON THE DISTAL TIP CAN CAUSE THE TIP TO FLARE." THE INSTRUCTIONS STATE WHAT SIZE OF STRIPPER TO USE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHILE USING THE ENDOSTAT FIBER, A FLAME CAME OUT OF THE END OF THE FIBER. THE FLAME WAS IMMEDIATELY EXTINGUISHED USING A WET TOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT FIBER FIBER GEX AMERICAN MEDICAL SYSTEMS NA 923

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other