BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3042286 · Received April 1, 2013

    Report

    Report Number
    2937094-2013-00416
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 8, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR REPORT #: 2937094-2013-00417. FIBER ANALYSIS: THE FIBER CAP REMAINS INTACT AND ATTACHED; EXHIBITS A DRILLED THROUGH CONDITION. DEVITRIFICATION WAS OBSERVED ON THE FIBER CAP NEAR THE DRILL HOLE. THE FIBER CONNECTOR WAS TESTED AND THE REPORTED FIBER PORT OVERHEAT ISSUE COULD NOT BE REPRODUCED OR CONFIRMED. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; LIKELY RESULTING IN A DIFFUSE BEAM ND 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 THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE LOCALIZED HEAT ACCUMULATION DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE; CAP WEAR WAS ACCELERATED LIMITED THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, A "FIBER PORT OVERHEATED MESSAGE" WAS REC'D AT 20 JOULES OF USE; THE FIBER WAS REPLACED AND THE PROCEDURE CONTINUED USING A SECOND FIBER. AT 90,237 JOULES OF USE, A PROSTATE STONE WAS HIT, RESULTING IN DAMAGE TO THE FIBER TIP; THE SECOND FIBER WAS REPLACED AND THE CASE WAS COMPLETED USING A THIRD FIBER. PT OUTCOME: "NO PT INJURY, OUTCOME OF PT WAS FINE." THIS REPORT IS FOR THE FIRST FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132176 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 219H

    Patients

    Seq Age Sex Outcome Treatment
    1