BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3791998 · Received May 6, 2014

    Report

    Report Number
    2937094-2014-00345
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    December 6, 2013
    Report Date
    March 7, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER MODEL #0010-2400; LOT #331B; SERIAL # (B)(4): THE FIBER SHOWS A RADIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITS SEVERE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THERE IS MISALIGNMENT OF METAL CAP OUTPUT WINDOW WITH THE RED STOP SIGN; THE METAL CAP IS NOT LOOSE WITHIN THE OUTER FLOW TUBING. BASED ON THE ANALYSIS ABOVE, THE POTENTIAL FOR FORWARD FIRING MAY 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 HAD DIMINISHED VAPORIZATION AND FIBER TIP DISPLACE" AT 29 MINUTES AND 236,778 JOULES OF USE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. PATIENT OUTCOME: "NO INJURY TO PATIENT REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270226 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 331B

    Patients

    Seq Age Sex Outcome Treatment
    1