BEUDAMED
    FDA Adverse Event Other Summary report: N

    GREENLIGHT HPS

    MDR report key: 1736310 · Received June 21, 2010

    Report

    Report Number
    2937094-2010-00005
    Event Type
    Other
    Date Received
    June 21, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 21, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THE PT WAS DOING FINE. AMERICAN MEDICAL CENTER'S CUSTOMER SERVICE ENGINEER VISITED THE SITE AND WAS UNABLE TO DUPLICATE THE ERROR THE CUSTOMER EXPERIENCED. THE SYSTEM FOOTSWITCH FUNCTION CHECKED MANUALLY AND FROM THE COMPUTER DATA AND NO PROBLEMS WERE FOUND WITH THE SYSTEM. LASER SYSTEM IS IN SPECIFICATION. CONTACT WAS MADE WITH THE BIOMED AT THE FACILITY AND NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME. THE FOOTSWITCH WAS NOT RETURNED TO AMS AND THERE HAVE BEEN NO FURTHER PROBLEMS REPORTED. AMS IS STILL INVESTIGATING THIS EVENT. A FOLLOW UP MEDWATCH REPORT WILL BE SENT IF MORE INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT DURING A GREENLIGHT PVP (PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE) PROCEDURE, THE LASER FIRED WITHOUT THE FOOTPEDAL BEING PRESSED. THE PT RECEIVED A SMALL BURN ON THE INTERIOR BLADDER WALL. A STINT WAS PLACED FOR PRECAUTIONARY MEASURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other