BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4063192 · Received September 5, 2014

    Report

    Report Number
    2937094-2014-00798
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 25, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/GLASS CAP FUSION ZONE PROXIMAL TO THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP AND METAL CAP ARE DETACHED AND NOT RETURNED; THE GLASS CAP DOES NOT EXHIBITS DETRITUS ADHESION; THE OUTER FLOW TUBING IS TORN AT THE OPEN END. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS:MECHANICAL FORCE DURING USAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER FOR 15 MINUTES DURING A PROSTATE PROCEDURE, AN ERROR MESSAGES OCCURRED. THE FIBER WAS REPLACED AND THE CASE CONTINUED FOR 2 MINUTES, THEN FIBER FUNCTION ISSUES WERE OBSERVED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE PROCEDURE / WITH A RESECTOR (TURP). THERE WAS NO PATIENT INJURY REPORTED. THIS REPORT IS FOR THE FIRST SURGICAL FIBER USED. GLAND VOLUME: 80 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545621 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 404A

    Patients

    Seq Age Sex Outcome Treatment
    1