BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 2940962 · Received January 29, 2013

    Report

    Report Number
    2937094-2013-00151
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 12, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER CAP REMAINS INTACT AND ATTACHED, EXHIBITS A DRILLED THROUGH CONDITION. THE FIBER CAP EXHIBITS DETRITUS, CHAR, DEVITRIFICATION AND MELTED GLASS. THE BEVEL SECTION IS MELTED AND BURNT. THE FIBER CAP CONDITION WOULD RESULT IN REDUCED VAPORIZATION. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND/OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. REF: 2937094-2013-00150.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER WAS DAMAGED AT THE TIP AT 18,048 JOULES DURING THE PROCEDURE. A SECOND FIBER USED RESULTED IN A DAMAGED TIP AT 67,457 JOULES. A THIRD FIBER WAS USED TO COMPLETE THE PROCEDURE. "NO INJURY TO PATIENT, OUTCOME OK." THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39361 GREENLIGHT HPS FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 226H

    Patients

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