BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB SUCTION COAGULATOR 10FR

    MDR report key: 2250656 · Received September 2, 2011

    Report

    Report Number
    2250656
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 2, 2011
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN VALLEYLAB SUCTION COAGULATOR E3310 WAS OPENED ONTO THE STERILE FIELD IN THE OR. STAFF NOTICED INSULATION WASN'T FULLY COVERING THE WIRES SO IT WAS REMOVED FROM THE FIELD. ANOTHER COAGULATOR WAS OBTAINED AND USED FOR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB SUCTION COAGULATOR 10FR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE * 211326X

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR NONE NOTED| NO OTHER THERAPIES