BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3931214 · Received July 14, 2014

    Report

    Report Number
    2937094-2014-00600
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 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 #405A; SERIAL #(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 METAL CAP EXHIBITS SEVERE CHAR AND MELTED METAL AT THE OUTPUT WINDOW; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE GLASS CAP IS PROTRUDING FROM THE METAL CAP; THE METAL CAP ADHESION LOCATION EXHIBITS BURNT GLUE. 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 FIRST FIBER ISSUE ¿CONSOLE BLOCKED STAYS IN WAITING MODUS, MENU CODE 171" AT 63346 JOULES AT 9:41 MINUTE OF LASING TIME. THE FIBER WAS EXCHANGED; THE SECOND FIBER ISSUE ¿CONSOLE BLOCKED STAYS IN WAITING MODUS, MENU CODE 171¿ AT 221,070 JOULES AT 24:01 MINUTES OF LASING TIME THE FIBER WAS EXCHANGED; THE THIRD FIBER ISSUE ¿GENERATOR FAILURE¿ AT 127,677 JOULES AT 13:32 MINUTES OF LASING TIME, THE FIBER WAS EXCHANGED AND THE CASE COMPLETED. PATIENT OUTCOME: ¿NO DAMAGED TO THE PATIENT¿ REPORTED. THIS REPORT IS FOR THE THIRD FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411371 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 405A

    Patients

    Seq Age Sex Outcome Treatment
    1