BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4242359 · Received November 11, 2014

    Report

    Report Number
    2937094-2014-01035
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 17, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER/GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO THE FIBER/GLASS CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITS MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MODERATE BURN MARKS AT THE OUTPUT AREA LOCATION AND MODERATE DETRITUS ADHESION CHAR. BASED ON THE ANALYSIS, 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 WOULD LIMIT THE PERFORMANCE OF THE FIBER. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 213,283 JOULES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER CAP BEGAN TURNING (ROTATING INDEPENDENTLY OF THE FIBER) AND NOT FIRING STRAIGHT. TIME EXPENDED: 35:28 MINUTES. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP). THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727687 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 402A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other