BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGELED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2553684 · Received April 25, 2012

    Report

    Report Number
    2937094-2012-00426
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    October 13, 2011
    Report Date
    October 19, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND ANALYZED. THE CUSTOMER'S INITIAL REPORT OF DIMINISHED VAPORIZATION EFFICIENCY, IS NOT CONSIDERED A REPORTABLE ISSUE. UPON ANALYSIS OF THE RETURNED FIBER, THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE PROXIMAL TO THE FIBER/CAP FUSION ZONE. THE CAP WAS ALSO FOUND TO HAVE BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW. THE FIBER CONDITION WOULD LIKELY RESULT IN ACTIVATION OF THE SYSTEM FIBERLIFE FUNCTION WHICH WILL MODULATE (PULSE) THE OUTPUT BEAM, RESULTING IN REDUCED TISSUE VAPORIZATION EFFICIENCY AND OR SEND THE SYSTEM TO STANDBY MODE. BASED ON THE ANALYSIS FINDINGS, THE CIRCUMFERENTIAL FRACTURE CONDITION MAY ALSO RESULT IN A FORWARD FIRING CONDITION, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL SAFETY ISSUE. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, RESULTING IN FIBER BREAKAGE AND CAP DAMAGE. THE PRODUCT LABELING WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SIGNIFICANTLY DIMINISHED VAPORIZATION EFFICIENCY AT 20,000 JOULES. THE CASE WAS COMPLETED USING TURP. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGELED DELIVERY DEVICE, GREENLIGHT XPS SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-2400 130A

    Patients

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