BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2597056 · Received May 31, 2012

    Report

    Report Number
    2937094-2012-00608
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    July 10, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIBERLIFE MESSAGE REPORTED BY THE CUSTOMER IS NOT CONSIDERED TO BE REPORTABLE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE MFR AND ANALYZED. JOULES WERE VERIFIED ON THE FIBER CARD AS 243,990 JOULES. FAILURE ANALYSIS DISCLOSED A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP PROXIMAL TO THE FIBER/CAP FUSION ZONE. THE FIBER PROXIMAL TO THE FRACTURE CAN ROTATE INDEPENDENTLY OF THE METAL CAP. THIS CAP CONDITION IS INDICATIVE OF A FRACTURE OF THE GLASS CAP, BENEATH THE METAL CAP, AND MAY ACTIVATE THE FIBERLIFE FUNCTION. THE METAL CAP HAS BURNT ON DETRITUS AND DEVITRIFICATION AT THE OUTPUT WINDOW, AND THE GLUE HAD BEEN HEATED TO THE POINT OF BURNING, CAUSING THE GLASS CAP TO BECOME LOOSE AND BE PUSHED FORWARD INSIDE THE METAL CAP. FIBERLIFE WOULD MODULATE THE POWER, SHOWING A PULSING BEAM, OR PLACE THE SYS INTO STANDBY MODE. THIS CAP CONDITION MAY ALSO CAUSE FORWARD FIRING OF THE SIDE-FIRING FIBER, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL SAFETY ISSUE. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION, LIKELY DUE TO TISSUE CONTACT AND/OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, ACCELERATING CAP WEAR AND LIMITING THE PERFORMANCE OF THE FIBER. THE PRODUCT LABELING WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE THE FIBER DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FIBER WOULD NOT STOP FLASHING THE FIBERLIFE SAFETY MESSAGE AT 244,010 JOULES DURING A PROSTATE PROCEDURE. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. THE PT OUTCOME WAS REPORTED AS "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT XPS SURGICAL FIBER GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-2400 120A

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT XPS SURGICAL LASER SYS| AND ACCESSORIES