BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 6795721 · Received August 15, 2017

    Report

    Report Number
    2937094-2017-00730
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Date of Event
    July 27, 2017
    Report Date
    July 27, 2017
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE ON THE DISTAL SIDE OF FIBER/CAP FUSION ZONE OF THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT OUTPUT WINDOW; THE METAL CAP EXHIBITS SEVERE DETRITUS ADHESION ON SURFACE, AND INDICATIONS OF SLIGHT MELTING ON OUTPUT WINDOW; THE OUTER FLOW TUBING OPEN END EXHIBITS MINOR SCRATCH MARKS, AND MILD CONTAMINATION, LIKELY BIOLOGIC. BASED ON DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE DEVICE ANALYSIS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, WITH 49,255 JOULES USED, IT WAS NOTED THAT THE "FIBER TIP WAS FLOATING IN HOUSING". THE FIBER WAS EXCHANGED AND THE SECOND FIBER WAS UTILIZED, WITH 153647 JOULES USED, TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575348 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 713A

    Patients

    Seq Age Sex Outcome Treatment
    1