BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2081121 · Received April 14, 2011

    Report

    Report Number
    2937094-2011-00685
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE MIDDLE OF THE PROCEDURE ERRORS 171 AND 211 WERE RECEIVED FROM THE LASER SYSTEM. PER THE CUSTOMER , THE LASER SYSTEM WAS SHUT OFF THREE TIMES. ALSO, THE CUSTOMER REPORTED THAT AFTER THE THIRD TIME OF SHUTTING OFF THE LASER SYSTEM, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO FURTHER ISSUES. 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 Other