BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3946205 · Received July 21, 2014

    Report

    Report Number
    2937094-2014-00640
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE DISTAL TO THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITS SEVERE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIRST FIBER ISSUE ¿THE FIBER STOPPED ROTATING, LIKE THE INNER AND OUTER SHEATH BECAME SEPARATED". AT 191,039 JOULES. THE FIBER WAS EXCHANGED; THE SECOND FIBER ISSUE ¿AIM BEAM FIRES STRAIGHT OUT OF THE FIBER" AT 39,657 JOULES. THE FIBER WAS EXCHANGED; THE THIRD FIBER ISSUE ¿AIM BEAM FIRES STRAIGHT OUT OF THE FIBER" AT 50,559 JOULES. THE FIBER WAS EXCHANGED, THE FOURTH FIBER ISSUE "AIM BEAM FIRES STRAIGHT OUT OF THE FIBER" AT 74,296 JOULES. THIS FIBER WAS ALSO USED TO COMPLETE THE CASE. PATIENT OUTCOME: NO PATIENT OR USER INJURY REPORTED. THIS REPORT IS FOR THE 4TH FIBER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424470 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 401A

    Patients

    Seq Age Sex Outcome Treatment
    1