BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SONIX

    MDR report key: 480776 · Received August 21, 2003

    Report

    Report Number
    MW1029382
    Event Type
    Malfunction
    Date Received
    August 21, 2003
    Date of Event
    August 18, 2003
    Report Date
    August 19, 2003
    Manufacturer
    U.S. SURGICAL
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AUTOSONIC HOOK PROBE 5MM. LOT # NOL336 EXP. 12/05 INSERTED THROUGH 10 MM PORT. WHEN ACTIVATED THE GENERATOR MADE A LOUD BUZZING NOISE - SHUT OFF AND PROBE REMOVED AND TIP WAS MISSING. X-RAY - (+) FOR FOREIGN BODY. ABDOMEN SEARCHED LAPAROSCOPICALLY AND UNABLE TO LOCATE FOREIGN BODY. PT. CLOSED AND NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SONIX GENERATOR LFL U.S. SURGICAL * *
    2 AUTO SONIX PROBE LFL US SURGICAL * N0L336

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other