BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2062259 · Received April 12, 2011

    Report

    Report Number
    2937094-2011-00616
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, DURING THE PROCEDURE, ERROR MESSAGE CODES 210 AND 235 OCCURRED. PER THE CUSTOMER, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO FURTHER ISSUES. 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