BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2842008 · Received November 14, 2012

    Report

    Report Number
    2937094-2012-01236
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 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
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE LASER SYSTEM DISPLAYED AN ERROR INDICATIVE OF A SYSTEM MALFUNCTION. CUSTOMER WAS CONNECTED WITH TECHNICAL SUPPORT TO TROUBLE SHOOT THE ISSUE. THE SYSTEM WAS SHUT DOWN SEVERAL TIMES AND REBOOTED HOWEVER THE ERROR PERSISTED. THE SYSTEM WAS NO LONGER ABLE TO BE UTILIZED. THERE WAS NO REPORT OF A PT INJURY; HOWEVER THE MANUFACTURER IS FILING THIS AS SURGICAL INTERVENTION DUE TO THE PT REQUIRING AND ADDITIONAL PROCEDURE AS A RESULT OF THE INCOMPLETION OF THE CASE.

    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)