BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3982981 · Received August 6, 2014

    Report

    Report Number
    2937094-2014-00683
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER 0010-2400-308A-(B)(4): THE FIBER EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITED SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITED SEVERE BURNT ON DETRITUS; THE OUTER FLOW TUBING EXHIBITED MODERATE SINGS OF MELTING, AND CONTAMINATION (LIKELY BIOLOGIC) AT THE OPEN END. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY ALSO 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 LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 57,673 JOULES OF USE, WHILE CLEANING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, A "FIBER EXPIRED" MESSAGE WAS RECEIVED. THE CASE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP), AS THE PHYSICIAN DID NOT WANT TO OPEN ANOTHER FIBER. THE PATIENT OUTCOME WAS REPORTED AS "OK" - THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460776 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 308A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other