BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3840796 · Received May 30, 2014

    Report

    Report Number
    2937094-2014-00423
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 17, 2014
    Report Date
    April 10, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE PROXIMAL TO THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITED SEVERE BURNT ON DETRITUS; THE GLASS CAP HAS PUSHED FORWARD IN METAL CAP AND WAS PROTRUDING FROM DISTAL END OF THE METAL CAP; THE GLASS CAP EXHIBITED SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE OUTER FLOW TUBE EXHIBITED SCRATCH MARKS AT THE OPEN END. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY ALSO EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH 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, THE FIBER WAS BURNED AT 45,000 JOULES. OUTCOME: "NO DAMAGES TO THE PATIENT". GLAND VOLUME: 80 ML. TIME EXPENDED: 18 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318688 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 312B

    Patients

    Seq Age Sex Outcome Treatment
    1