BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUMPET VALVE

    MDR report key: 12746 · Received April 14, 1994

    Report

    Report Number
    MW1001586
    Event Type
    Other
    Date Received
    April 14, 1994
    Date of Event
    March 17, 1994
    Report Date
    April 1, 1994
    Manufacturer
    DAVIS & GECK
    Product Code
    FEH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING A TRUMPET VALVE ON A LAPAROSCOPIC CHOLECYSTECTOMY FOR CAUTERY, SUCTION, AND IRRIGATION, THE INSULATION FRAYED AND THE GALLBLADDER WAS PERFORATED. BILE LEAKED INTO THE ABDOMINAL CAVITY. THE SURGEON WAS ABLE TO CONTROL THE EVENT AND COMPLETED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUMPET VALVE ENDOSCOPIC ELECTRODE SUCTION, IRRIGATION, CAUTERY FEH DAVIS & GECK 110372

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other