BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2222870 · Received August 10, 2011

    Report

    Report Number
    2937094-2011-01623
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 CODE 172 APPEARED AND THE LASER SYSTEM STOPPED. PER THE CUSTOMER, THE LASER SYSTEM STOPPED 3 TIMES DURING THE PROCEDURE (I.E., EXPERIENCED ERROR MESSAGE CODE 172) WHICH CAUSED THE LASER SYSTEM TO SHUT DOWN. THE CUSTOMER REPORTED THE LASER SYSTEM WAS REBOOTED DURING THE PROCEDURE MULTIPLE TIMES. PER THE CUSTOMER, THE PROCEDURE WAS ABLE TO BE COMPLETED. 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 AMS, INNOVATION CENTER - SILICON VALLEY 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1