BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LECTROVAC 6-INCH

    MDR report key: 1160703 · Received August 29, 2008

    Report

    Report Number
    1717344-2008-00408
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION, THE SAMPLE HAD DRIED BLOOD IN THE SUCTION PORT. THE SAMPLE PASSED HIPOT TESTING AND FUNCTIONED NORMALLY WHEN ACTIVATED ON A GENERATOR. THE IFU FOR THIS DEVICE STATES TO ENSURE THAT THE OUTSIDE OF THE COAGULATOR SUCTION TUBE REMAINS FREE OF FLUIDS AND MUCUS. CONTAMINANTS MAY CONDUCT ELECTRICAL CURRENT RESULTING IN PATIENT BURNS.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY, THE SURGEON WAS USING A SUCTION COAGULATOR TO COMPLETE THE TONSILLECTOMY. WHEN HE PLACED HIS FINGER OVER THE HOLE TO SUCTION, HE WAS BURNED AND RECEIVED A BLISTER ON HIS FINGER. THE PATIENT WAS NOT AFFECTED. THE GENERATOR WAS SET AT 15 CUT/40 COAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LECTROVAC 6-INCH ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 141774

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK