BEUDAMED
    FDA Adverse Event Other Summary report: N

    CO2 LASER

    MDR report key: 234723 · Received July 27, 1999

    Report

    Report Number
    234723
    Event Type
    Other
    Date Received
    July 27, 1999
    Date of Event
    July 22, 1999
    Report Date
    July 27, 1999
    Manufacturer
    SHARPLAN
    Product Code
    EWG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING A SHAPLAN LASER TO PERFORM AN ADENODECTOMY. THE SHEATH THAT THE WAVEGUIDE WENT THROUGH BECAME VERY HOT WHEN IT CAME INTO CONTACT WITH THE PT'S LIP IT BURNED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO2 LASER LASER EWG SHARPLAN 1041 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other