BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3366463 · Received August 5, 2013

    Report

    Report Number
    2937094-2013-00867
    Event Type
    Malfunction
    Date Received
    August 5, 2013
    Date of Event
    April 8, 2013
    Report Date
    June 12, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES: FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER WAS FOUND TO BE FRACTURED AND PARTIALLY BROKEN OFF; THE REMAINING PORTION OF THE CAP WAS FOUND TO BE DRILLED THROUGH AND EXHIBIT CHAR AND DETRITUS. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE FIBER CONDITION COULD 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 DURING A PROSTATE PROCEDURE, TWO SURGICAL FIBERS FAILED TO REACH THEIR MAXIMUM JOULE LIMIT; THE FIRST FIBER WAS REPLACED AT 16,000 JOULES OF USE AND THE SECOND FIBER WAS REPLACED AT 18, 387 JOULES OF USE. THE PROCEDURE WAS COMPLETED USING A THIRD FIBER. THE PROCEDURE OUTCOME WAS REPORTED AS "NO INJURY TO THE PT." THIS REPORT IS FOR THE FIRST FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366592 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 251H

    Patients

    Seq Age Sex Outcome Treatment
    1