BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2992399 · Received March 1, 2013

    Report

    Report Number
    2937094-2013-00298
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    April 7, 2012
    Report Date
    February 20, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    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. THE SYSTEM WAS NO LONGER ABLE TO BE UTILIZED, AND THE PHYSICIAN CONVERTED TO "TURF" (AN ALTERNATIVE SURGICAL PROCEDURE). THE PATIENT CONDITION WAS REPORTED TO BE "NO HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89922 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-0075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other