BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2913124 · Received January 8, 2013

    Report

    Report Number
    2937094-2013-00039
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    February 20, 2012
    Report Date
    May 21, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIBER ANALYSIS: THOUGH THE FIBER WAS REPORTED TO HAVE BEEN UNUSED (0 JOULES OF USE), THE FIBER WAS VERIFIED TO HAVE 102,990 JOULES OF USAGE. THE FIBER CAP WAS FOUND TO BE DRILLED THROUGH AND EXHIBITED DETRITUS, CHAR, 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 ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT 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 PRIOR TO BEGINNING A PROSTATE PROCEDURE, THE SIDE-FIRING SURGICAL FIBER (AIMING BEAM) WAS OBSERVED TO BE FORWARD FIRING; 0 JOULES OF FIBER USE REPORTED. THE CASE WAS COMPLETED BY TURP. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10079 AMS GREENLIGHT HPS FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 119H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| GREENLIGHT HPS LASER SYSTEM