BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONELIGHT LASER SYSTEM

    MDR report key: 2092129 · Received April 27, 2011

    Report

    Report Number
    2937094-2011-00823
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K994273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE LASER DID NOT RESUME OPERATION AFTER THE LASER SYS WAS PUT ON STANDBY MODE. PER THE CUSTOMER, THE LASER DID NOT STAY POWERED ON WHILE TRYING TO COMPLETE THE PROCEDURE. ALSO, IT WAS REPORTED THE PROCEDURE WAS RESCHEDULED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONELIGHT LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-9260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other