BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COHERENT

    MDR report key: 17906 · Received September 2, 1994

    Report

    Report Number
    17906
    Event Type
    Malfunction
    Date Received
    September 2, 1994
    Date of Event
    August 23, 1994
    Report Date
    August 23, 1994
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING HOLMIUM LASER FOR KNEE SURG. HE WAS LEANING HEAVILY ON THE LASER FIBER CARRYING THE LASER BEAM TO THE HANDPIECE. AS HE WAS REMOVING THE HANDPIECE FROM THE PT'S KNEE AND THE LASER WAS IN STANDBY, A CRACKLING SOUND WAS HEARD. THE FIBER SEPARATED FROM THE HANDPIECE AND WAS BURNING LIKE A FUSE DOWN THE FIBER. THE LASER WAS TURNED OFF AND THE HANDPIECE PLACED IN A BOWL OF WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHERENT LASER HANDPIECE GEX COHERENT MEDICAL GROUP 0614-459-03 060394

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other