BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YAG/KTP LASER

    MDR report key: 2012197 · Received March 3, 2011

    Report

    Report Number
    MW5019679
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 3, 2011
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IN OPERATING ROOM FOR YAG LASER BRONCHOSCOPY AS TREATMENT FOR OBSTRUCTING TRACHEAL/MAINSTEM BRONCHIAL CANCER; COMPLETE LEFT LUNG ATELECTASIS. DURING PROCEDURE THERE WAS A FLARE UP OF THE LASER. THIS LASER WAS TAKEN OUT OF SERVICE AND SENT TO ISS. ANOTHER LASER OBTAINED AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YAG/KTP LASER GEX 1064

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR