BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRODE, PTFE, INS BLADE 2.5"

    MDR report key: 1830223 · Received September 7, 2010

    Report

    Report Number
    1417592-2010-00052
    Event Type
    Other
    Date Received
    September 7, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DURING A TONSILLECTOMY. THE SURGEON HAD REMOVED ONE TONSIL AND WAS REMOVING THE OTHER SIDE WHEN HE STATES HE SAW AN ARC FROM THE CAUTERY PENCIL. THE PATIENT SUFFERED A MINOR BURN TO BOTH CORNERS OF THE MOUTH. THE PENCIL HAD BEEN USED INTERMITTENTLY DURING THE PROCEDURE. THE ACCOUNT IS NOT AWARE OF THE TIP COMING IN CONTACT WITH ANY METAL INSTRUMENTS. OINTMENT WAS APPLIED TO THE CORNERS OF THE PATIENT'S MOUTH. NO FURTHER TREATMENT WAS NECESSARY. THE SAMPLE WAS RETURNED AND EVALUATED. A CHAR MARK WAS FOUND ON THE RETURNED PENCIL CLOSE TO WHERE THE TIP SHOULD BE SEATED. CHAR MARKS AND BLOOD STAINS WERE FOUND ON THE TIP (BOTH TIP AND THE INSULATION). UPON RECEIPT, THE TIP WAS SEATED CORRECTLY INTO THE PENCIL. HOWEVER, WHEN SEPARATING THE TIP FROM THE PENCIL, CHAR MARKS COULD BE FOUND ON THE METAL PART OF THE TIP AND AT THE END OF THE INSULATION AROUND THE METAL PART. WHEN THE TIP IS SEATED CORRECTLY ON THE PENCIL, BOTH SHOULD BE COMPLETELY INSIDE THE PENCIL. VARIOUS SCENARIOS WERE USED TO TEST IN AN ATTEMPT TO DUPLICATE THE REPORTED INCIDENT. TEST 1 WAS DONE AT A SETTING OF 30-30, WITH THE TIP SEATED CORRECTLY. WE CYCLED THE PENCIL IN BOTH CUT AND COAG FOR 10 TIMES; WE REVIEWED THE TIP AFTER A TOTAL OF 20 CYCLES. CHAR MARKS WERE FOUND ON THE TIP, BUT NO CHAR MARK ON THE INSULATION AND NO CHAR MARK ON THE METAL PART. TEST 2 WAS DONE AT A SETTING OF 30-30 WITH THE TIP SEATED CORRECTLY. THE ENTIRE TIP WAS LAID ON A PIECE OF CHICKEN BREAST AND THE PENCIL WAS ACTIVATED BY PUSHING THE SWITCH, AND THEN HOLDING THE SWITCH FOR 15 SEC. THIS WAS REPEATED TWICE. THE TIP WAS REVIEWED AFTER THE TEST. CHAR MARKS COULD BE FOUND ON THE TIP AND THE INSULATION AROUND THE TIP, BUT STILL NO CHAR MARK ON THE METAL OR AT THE END OF THE INSULATION (NEXT TO THE METAL PART). TEST 3 WAS DONE AT A SETTING OF 30-30, WITH THE TIP DID NOT SEATED COMPLETELY ON THE PENCIL WITH PART OF THE METAL EXPOSED. IT WAS THEN LAID ON A PIECE OF CHICKEN BREAST AND WE ACTIVATED THE PENCIL BY PUSHING THE SWITCH, HOLDING THE SWITCH FOR 15 SEC AND REPEATING THIS TWICE. THE TIP WAS REVIEWED AFTER THE TEST. CHAR MARKS WERE FOUND ON THE TIP, ON THE INSULATION (INCLUDING THE END OF THE INSULATION AROUND THE METAL PART), AND THE METAL PART. WE WERE UNABLE TO DUPLICATE THE CONDITION OF THE RETURNED SAMPLE WHEN THE TIP WAS SEATED CORRECTLY INTO THE PENCIL; BUT WAS ABLE TO DUPLICATE THE CONDITION WHEN THE TIP WAS NOT SEATED CORRECTLY WITH PART OF THE METAL EXPOSED. BASED ON THE INFORMATION GATHERED DURING THE TESTING WE HAVE DETERMINED THE INCIDENT WAS THE RESULT OF USER ERROR. DUE TO THE REPORTED BURN, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED A MINOR BURN FROM THE CAUTERY TIP DURING A TONSILLECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, PTFE, INS BLADE 2.5" NONE GEI MEDLINE INDUSTRIES, INC. ES0012M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other