BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3962837 · Received July 29, 2014

    Report

    Report Number
    2937094-2014-00664
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER MODEL #0010-2400, LOT 406A, SERIAL #(B)(4): THE FIBER EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITED SEVERE BURNT ON DETRITUS; THE GLASS CAP EXHIBITED SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE OUTER FLOW TUBING EXHIBITED SEVERE CONTAMINATION, LIKELY BIOLOGIC. 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 DURING A PROSTATE PROCEDURE, THE FIBER CAP WAS OBSERVED TO "BE MOVING" / ROTATE INDEPENDENTLY OF THE FIBER. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. THERE WAS NO PATIENT INJURY REPORTED. TIME EXPENDED: 32:20; JOULES USED: 110,700.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442222 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 406A

    Patients

    Seq Age Sex Outcome Treatment
    1