BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3940346 · Received July 17, 2014

    Report

    Report Number
    2937094-2014-00631
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 13, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER MODEL #0010-2400; LOT #403B; SERIAL #1813: THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE DISTAL TO THE BEVEL EDGE; THE METAL CAP EXHIBITS MILD DETRITUS ADHESION; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; 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; THE OUTER FLOW TUBING IS MELTED AT THE LOCATION OF THE PROXIMAL FRACTURE; THE OUTER FLOW TUBING EXHIBITS MILD CONTAMINATION, LIKELY BIOLOGIC. 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. 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 FIBER MALFUNCTIONED AT 160,000 JOULES AND 25:00 MINUTES OF USAGE. THE CASE WAS COMPLETED WITH A SECOND FIBER. PATIENT OUTCOME: "NO DAMAGES TO THE PATIENT" WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420432 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 403B

    Patients

    Seq Age Sex Outcome Treatment
    1