BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15 ELECTRODE DBL. INSULATED SPATULA TIP

    MDR report key: 541598 · Received August 30, 2004

    Report

    Report Number
    2916714-2004-00028
    Event Type
    Malfunction
    Date Received
    August 30, 2004
    Date of Event
    July 28, 2004
    Report Date
    August 30, 2004
    Manufacturer
    LIFE LINES MEDICAL, INC.( LIFE INSTRUMENT CORP.)
    Product Code
    KNF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LAPARASCOPIC GASTRIC BY-PASS AND CHOLECYSTECTOMY. BOVIE SPATULA CAUTERY WAS NOTED TO ARC DURING PROCEDURE. PT SUSTAINED 1 CM X .5 CM BURN ON SKIN OF RIGHT LOWER QUADRANT. DR PERFORMED PROCEDURE. INSULATION COMPROMISED, APPROX 4" FROM END WHERE IT CONNECTS TO BOVIE, ABOUT 1/8" VISIBLE METAL, CAUSED AN ARC WHICH BURNED PT. PT RECOVERED. SKIN WAS EXCISED AND REPAIRED. RISK MANAGER HAS PRODUCT IN POSSESSION AND UNABLE TO VERIFY PART NUMBER. SURGERY WAS PROLONGED LONG ENOUGH TO OBTAIN ANOTHER INSTRUMENT, -SHORT AMOUNT OF TIME (LESS THAN 5 MINUTES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15 ELECTRODE DBL. INSULATED SPATULA TIP BOVIE SPATULA CAUTERY KNF LIFE LINES MEDICAL, INC.( LIFE INSTRUMENT CORP.) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other