BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3842044 · Received May 31, 2014

    Report

    Report Number
    2937094-2014-00429
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 19, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE REPORT OF "CAP DETACHED" COULD NOT BE CONFIRMED; HOWEVER, THE FIBER EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE GLASS/METAL CAPS REMAINED INTACT AND ATTACHED; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITED SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITED SEVERE BURNT ON DETRITUS; THE OUTER FLOW TUBING EXHIBITED SEVERE CONTAMINATION, LIKELY BIOLOGIC. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER CAP DETACHED AT 216,000 JOULES AND 30 MINUTES OF USAGE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. ¿NO DAMAGE TO THE PATIENT¿ WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320575 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 347A

    Patients

    Seq Age Sex Outcome Treatment
    1