BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3984748 · Received August 6, 2014

    Report

    Report Number
    2937094-2014-00694
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 29, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER SHOWS A CIRCUMFERENTIAL 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 MODERATE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP ADHESION LOCATION EXHIBITS BURNT GLUE. 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 WOULD LIMIT THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, AT 190930 JOULES; 32 MINUTES AND 14 SECONDS IT WAS NOTED THAT THE FIBER HEAD BROKE INSIDE OF THE PATIENT. THIS FIBER WAS EXCHANGED; HOWEVER, THE SECOND FIBER WAS NOTED TO HAVE BROKEN INSIDE OF THE PATIENT. ADDITIONAL INFORMATION PROVIDED INDICATES THAT THE "FIBER HEAD" ON EACH OF THE FIBERS SEPARATED FROM THE FIBER AND THE ¿FIBER HEADS¿ WERE NOT RETRIEVED FROM THE INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE PROCEDURE (TURP). THIS REPORT IS FOR THE FIRST FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460800 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 410A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other