BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3983562 · Received August 6, 2014

    Report

    Report Number
    2937094-2014-00687
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE PROXIMAL TO THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITS MILD DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MILD DETRITUS ADHESION. 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 15,201 JOULES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER OVERHEATED. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. PATIENT OUTCOME: "OKAY" - THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461463 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 350B

    Patients

    Seq Age Sex Outcome Treatment
    1