BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3970097 · Received July 31, 2014

    Report

    Report Number
    2937094-2014-00675
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 21, 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

    (B)(4). PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/GLASS CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP AND METAL CAP ARE DETACHED; THE METAL CAP IS RETURNED; THE GLASS CAP EXHIBITS MODERATE DEVITRIFICATION AND MILD DETRITUS ADHESION; THE METAL CAP EXHIBITS SEVERE CHAR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER EXPIRED. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. NO ADDITIONAL INFORMATION PROVIDED. "NO DAMAGES TO THE PATIENT" REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, @ 110,300 JOULES USED; 12 MINUTES, THE "FIBER EXPIRED" AND ¿BREAKING OF THE METAL PART¿. THE FIBER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446870 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 333B

    Patients

    Seq Age Sex Outcome Treatment
    1