BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2932327 · Received January 22, 2013

    Report

    Report Number
    2937094-2013-00121
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    April 30, 2012
    Report Date
    May 1, 2012
    Manufacturer
    AMERICAN MED SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 GLASS CAP OF THE SURGICAL FIBER WAS FOUND TO BE DETACHED; THE FIBER IS BROKEN PROXIMAL TO THE FIBER/CAP FUSION ZONE; THE FIBER CAP WAS NOT RETURNED BY THE CUSTOMER. 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 ROOT CAUSE OF THE DEVICE THE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, RESULTING IN CAP DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, DIMINISHED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED AT 139,804 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. CURRENT STATUS OF THE PT: "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31630 GRENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MED SYSTEMS 10-2090 150H

    Patients

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