BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI INC.

    MDR report key: 1729582 · Received June 15, 2010

    Report

    Report Number
    MW5016422
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 1, 2010
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOLMIUM LASER STARTED MAKING POPPING SOUNDS. LIGHT GLIDE CHANGED IMMEDIATELY. UOR WAS DONE. LASER FIBER COMES 3 EACH IN BOX. WE DIDN'T HAVE ANY PROBLEM WITH OTHER TWO FIBERS AND USED MANY TIMES WITH OTHER LOT NUMBER'S FIBER. HAS BEEN NO PROBLEM. DIAGNOSIS OR REASON FOR USE: URETER STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS ACMI INC. LASER FIBER (LIGHT GUARD) GEX DUR40DD B04105

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR