BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2831224 · Received November 6, 2012

    Report

    Report Number
    2937094-2012-01078
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER SYSTEM DISPLAYED AN ERROR INDICATIVE OF A SYSTEM MALFUNCTION. FOUR FIBERS (FROM THREE DIFFERENT LOTS) WERE TRIED UNSUCCESSFULLY. THE LASER SYSTEM WAS NO LONGER ABLE TO BE UTILIZED; THEREFORE THE CASE WAS COMPLETED BY USING AN ALTERNATE SURGICAL PROCEDURE. THERE WAS NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER SYSTEM LASER SYSTEM GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SURGICAL FIBER (S)