BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3940336 · Received July 17, 2014

    Report

    Report Number
    2937094-2014-00634
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 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, US
    Reporter Occupation
    OTHER

    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 GLASS CAP EXHIBITS MILD DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MILD CHAR; THERE IS MISALIGNMENT OF THE METAL CAP OUTPUT WINDOW WITH THE RED STOP SIGN; THE METAL CAP IS LOOSE WITHIN THE OUTER FLOW TUBING. BASED ON THE ANALYSIS ABOVE, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PRODUCT COMPLAINT OF "CAP DETACHED" COULD NOT BE CONFIRMED; A CAP FRACTURE WAS OBSERVED; 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST FIBER WAS FORWARD FIRING @ 40,125 JOULES. THE SECOND FIBER WAS REPORTED TO HAVE A FIBER TIP DETACH @ 13,371 JOULES AND THE THIRD FIBER WAS FORWARD FIRING @ 14,245 JOULES. THE PROCEDURE WAS COMPLETED WITH A FOURTH FIBER @ 55,258 JOULES.PATIENT OUTCOME ¿OK¿. THIS REPORT IS FOR THE SECOND FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420293 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 401A

    Patients

    Seq Age Sex Outcome Treatment
    1