BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2219633 · Received August 11, 2011

    Report

    Report Number
    2937094-2011-01651
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THE LASER SYSTEM LEAKED OIL AND WATER DURING TWO CASES TWO SEPARATE TIMES. THE CUSTOMER CONFERENCED IN WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT WHO STATED THE CHILLER ON THE LASER SYSTEM NEEDED TO BE REPLACED. PER THE CUSTOMER, THE OUTCOME OF THE PROCEDURE WAS ALRIGHT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1