BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SONIX

    MDR report key: 306523 · Received November 27, 2000

    Report

    Report Number
    MW1020492
    Event Type
    Malfunction
    Date Received
    November 27, 2000
    Date of Event
    November 10, 2000
    Report Date
    November 27, 2000
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, THE ENDOSCOPIC ULTRASHEARS WERE PLACED ON THE PT'S ABDOMEN. UPON PICKING UP THE ULTRASHEERS A 3" BURN MARK WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SONIX ULTRASHEARS 5MM LONG LFL UNITED STATES SURGICAL 012033 U0K01

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other