BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3951871 · Received July 23, 2014

    Report

    Report Number
    2937094-2014-00651
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    January 15, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4):THE FIBER CAP REMAINED ATTACHED AND EXHIBITED A DRILLED THROUGH CONDITION; THERE WAS SOME WHITE UNKNOWN SUBSTANCE NOTED INSIDE THE FIBER CAP TIP; THE BEVEL SECTION IS MELTED; THE GLASS CAP EXHIBITED SEVERE BURNT ON DETRITUS AND DEVITRIFICATION; THE FIBER EXHIBITED SEVERE CONTAMINATION, LIKELY BIOLOGIC; THE FIBER WAS BLACKENED. THE CONDITION OF THE CAP AS DESCRIBED, COULD RESULT IN FORWARD FIRING.PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, CAP WEAR WAS ACCELERATED LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 46,370 JOULES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER TIP WAS DAMAGED.THE PROCEDURE WAS COMPLETED USING A SECOND FIBER.THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430644 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 316H

    Patients

    Seq Age Sex Outcome Treatment
    1