BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONELIGHT LASER SYSTEM

    MDR report key: 2172201 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01234
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE PROCEDURE, THE LASER SYSTEM CAUSED THE BREAKER TO TRIP. PER THE CUSTOMER, THE LASER WAS AT 15 AMP AND 10 WATTS. ALSO, THE CUSTOMER REPORTED THE LASER WAS IN CONTINUOUS USE DUE TO A LARGE STONE. THE CUSTOMER REPORTED THE PROCEDURE WAS COMPLETED. 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