BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 7279523 · Received February 18, 2018

    Report

    Report Number
    2937094-2018-00163
    Event Type
    Malfunction
    Date Received
    February 18, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 31, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR THE SAME EVENT AS MANUFACTURER REPORT 2937094-2018-001634.

    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 OUTER FLOW TUBING; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT OUTPUT WINDOW; THE METAL CAP EXHIBITS SEVERE CHARRED DETRITUS ADHESION ON SURFACE; 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 BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE, THE TIP ROTATED AND THE BEAM FIRED STRAIGHT OUT THE TIP AFTER 233,000 JOULES AND 30:24 MINUTES OF USE. THE FIBER WAS EXCHANGED. THE BEAM FIRED STRAIGHT OUT OF THE TIP OF THE SECOND FIBER AFTER 68,203 JOULES AND 9:12 MINUTES OF USE. THE PROCEDURE WAS COMPLETED UTILIZING THE THIRD FIBER. PATIENT OUTCOME: "FINE"; THERE WAS NO PATIENT INJURY REPORTED. THE TIPS (CAPS) OF BOTH FIBERS WERE NOT CLEANED DURING THE PROCEDURE. THIS REPORT IS FOR THE FIRST FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122785 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