BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOVIE BURN MACHINE (& PENCILS)

    MDR report key: 556200 · Received November 19, 2004

    Report

    Report Number
    556200
    Event Type
    Other
    Date Received
    November 19, 2004
    Date of Event
    November 12, 2004
    Report Date
    November 19, 2004
    Manufacturer
    VALLEYLAB - TYCO HEALTHCARE GRP US-SURGICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOVIE BURN MACHINE WAS THREADED THROUGH DRAPES DURING OPEN HEART SURGERY. WHEN TOWEL CLIPS WERE ATTACHED TO THE DRAPES, IT CUT THROUGH BOVIE WIRE WHICH WAS INADVERTENTLY LYING ON PT'S SKIN. STAFF UNAWARE UNTIL AFTER SURGERY. BURN APPROXIMATELY 3 INCHES LONG. SURGEON IMMEDIATELY ADDRESSED BY SUTURING AREA. AREA CLEANED AND SUTURED AT TIME OF OCCURRENCE. PT AWARE OF INCIDENT. PT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE BURN MACHINE (& PENCILS) SAME GEI VALLEYLAB - TYCO HEALTHCARE GRP US-SURGICAL T3J29121A A FORCE FC.C. *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other