BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4201618 · Received October 27, 2014

    Report

    Report Number
    2937094-2014-00977
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 18, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER 0010-2400-415A-(B)(4): THE FIBER/GLASS CAP EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITED MILD DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITED MILD BURNT ON DETRITUS. BASED ON THE ANALYSIS ABOVE, THE POTENTIAL FOR FORWARD FIRING MAY ALSO 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 LIMITING THE PERFORMANCE OF THE FIBER. (B)(4) REFERS TO FORWARD FIRING OF THE SIDE FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, "THE TIP OF THE LASER BURNED OFF AFTER BEING USED ON PROSTATE STONES". THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. THERE WAS ¿NO INJURY TO PATIENT¿ REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681283 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 415A

    Patients

    Seq Age Sex Outcome Treatment
    1