BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3111575 · Received May 6, 2013

    Report

    Report Number
    2937094-2013-00544
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE FRACTURED AND PARTIALLY BROKEN DISTAL TO THE ADHESION ZONE. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. 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 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 WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, DECREASED TISSUE VAPORIZATION WAS OBSERVED AT 12,300 JOULES OF USE; THE FIBER WAS EXCHANGED AND THE CASE CONTINUED USING A SECOND FIBER WHICH WOULD NOT FIRE/CEASED TO FIRE AT 18,643 JOULES OF USE. THE CASE WAS COMPLETED USING A THIRD FIBER. THERE WAS NO INJURY REPORTED. THIS REPORT IS FOR THE SECOND FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197530 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 208H

    Patients

    Seq Age Sex Outcome Treatment
    1