BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3951986 · Received July 23, 2014

    Report

    Report Number
    2937094-2014-00653
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): FIBER WAS BROKEN WITHIN THE OUTER FLOW TUBING NEAR THE CONTROL KNOB, BETWEEN THE CONTROL KNOB AND DISTAL END OF THE FIBER SIDE (14 INCHES FROM DISTAL END OF THE FIBER SIDE); THE FIBER WAS TESTED WITH HENE LASER FIXTURE, AIM BEAM WAS VISIBLE AT FIBER BREAK; THE OUTER SHEATH EXHIBITED STRETCH MARKS AT THE BREAK POINT; THE GLASS CAP EXHIBITED MILD DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITED MILD BURNT ON DETRITUS. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: EXCESSIVE BENDING/USE HANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER BROKE AT THE HANDLE. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT OUTCOME: "OK" - THERE WAS NO INJURY REPORTED. GLAND VOLUME: 70 ML. TIME EXPENDED: 16:35 MINUTES. JOULES USED: 105,642.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431912 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 408A

    Patients

    Seq Age Sex Outcome Treatment
    1