BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2092108 · Received April 27, 2011

    Report

    Report Number
    2937094-2011-00847
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 IN THE MIDDLE OF THE PROCEDURE A LOW WATER MESSAGE WAS REC'D FROM THE LASER SYS. PER THE CUSTOMER, THE PROCEDURE WAS COMPLETED AFTER ADDING WATER. YET, THE LOW WATER MESSAGE REMAINED ON THE LASER SYS SCREEN. ALSO, THE CUSTOMER REPORTED THAT ONCE THE PROCEDURE WAS COMPLETED, THERE WAS A LARGE PUDDLE OF WATER ON THE FLOOR BUT COULD NOT LOCATE WHERE THE WATER LEAK WAS COMING FROM. NO PT 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 Other