BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 6494026 · Received April 14, 2017

    Report

    Report Number
    2937094-2017-00350
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    December 16, 2016
    Report Date
    March 30, 2017
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE WAS EVALUATED AND REPAIRED IN THE FIELD ON DECEMBER 21, 2016. ERROR 213, 235, 302.13 AND 202.11 WERE OBSERVED. THE LASER POWER SUPPLY WAS REPLACED. NO FURTHER ERRORS WERE OBSERVED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER'S SPECIFICATIONS. THE REPLACED LPS S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON JANUARY 03, 2017. IT WAS NOTED THAT THE LPS WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GREEN LIGHT LASER VAPORIZATION OF THE PROSTATE, A POPPING SOUND FROM THE LASER MACHINE WAS HEARD AND THE LASER SHUT DOWN. AN ATTEMPT TO REBOOT THE LASER WAS UNSUCCESSFUL. AN ALTERNATIVE PROCEDURE (MONOPOLAR RESECTION) WAS USED TO THE COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274926 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR