BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3962848 · Received July 29, 2014

    Report

    Report Number
    2937094-2014-00668
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 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

    FAILURE ANALYSIS FOR FIBER MODEL #0010-2400, LOT #408A, SERIAL #(B)(4): THE FIBER SHOWS A RADIAL 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 SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MODERATE CHAR; THE FIBER CAP ALSO EXHIBITS SIGNS OF A CIRCUMFERENTIAL FRACTURE OF GLASS CAP PROXIMAL TO FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THIS FAILURE MODE IS INDICATIVE OF A FRACTURE BENEATH THE METAL CAP. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PRODUCT COMPLAINT OF "FIBER CONNECTION ERROR" COULD NOT BE CONFIRMED; A CAP FAILURE WAS OBSERVED; THE PROBABLE ROOT CAUSE OF THIS 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 WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, A FIBER CONNECTION ERROR OCCURRED; THE ERROR WAS CLEARED AND THE PROCEDURE CONTINUED. AT 31,375 JOULES OF USE, THE FIBER CONNECTION ERROR REOCCURRED, ALONG WITH AN "EXCESSIVE FIBER LIFE" ERROR MESSAGE. THE FIBER WAS REPLACED AND THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. THERE WAS NO PATIENT INJURY REPORTED. GLAND VOLUME: 40 ML; TIME EXPENDED: 3:55 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442027 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 408A

    Patients

    Seq Age Sex Outcome Treatment
    1