BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3102781 · Received May 3, 2013

    Report

    Report Number
    2937094-2013-00531
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    December 4, 2012
    Report Date
    February 27, 2013
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE ATTACHED AND INTACT, HOWEVER, DRILLED THROUGH. THE CAP WAS ALSO FOUND TO EXHIBITING DETRITUS AND DEVITRIFICATION. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; LIKELY RESULTING IN A DIFFUSE BEAM AND REDUCED TISSUE VAPORIZATION EFFICIENCY. THE DRILLED THROUGH FIBER CAP CONDITION MAY ALSO RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION/USER HANDLING DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER FLASHED AND STOPPED FIRING AT 6,217 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195488 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMS 10-2090 220H

    Patients

    Seq Age Sex Outcome Treatment
    1