BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 7365512 · Received March 23, 2018

    Report

    Report Number
    2937094-2018-00294
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 6, 2018
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE ON THE DISTAL SIDE OF FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE DISTAL PART OF GLASS CAP AND METAL CAP IS DETACHED AND NOT RETURNED; THE GLASS CAP EXHIBIT SEVERE DEVITRIFICATION AT OUTPUT WINDOW; THE OUTER FLOW TUBING OPEN END EXHIBITS MINOR SCRATCH MARKS. BASED ON DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE DEVICE ANALYSIS, 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 DURING A BPH SURGICAL PROCEDURE AT 2011761 JOULES AND 36:22 MINUTES THE TIP OF THE FIBER NO LONGER DELIVERING ENERGY PROPERLY WAS NOTED. THE FIBER WAS EXCHANGED AND AT 119,000 JOULES AND 12 MINUTES THE SAME PROBLEM WAS NOTED. THE FIBER WAS EXCHANGED AND THE THIRD FIBER WAS USED TO COMPLETE THE PROCEDURE. THE TIPS OF BOTH FIBERS WERE NOT CLEANED DURING THE PROCEDURE. NO HARM TO THE PATIENT REPORTED. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209241 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 21355245 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1