BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2553756 · Received April 25, 2012

    Report

    Report Number
    2937094-2012-00424
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    October 19, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND ANALYZED. THE CUSTOMERS INITIAL REPORT OF DIMINISHED VAPORIZATION, 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 SYSTEMS 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 DIMINISHED VAPORIZATION OF THE FIBER AT 73,634 JOULES. THE CASE WAS COMPLETED WITH A SECOND FIBER. THE PT'S OUTCOME WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT XPS SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-2400 128A

    Patients

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