BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAUTERY PENCIL PUSH BUTTON

    MDR report key: 1351570 · Received March 23, 2009

    Report

    Report Number
    1417592-2009-00019
    Event Type
    Other
    Date Received
    March 23, 2009
    Report Date
    March 13, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING A SHOULDER OR CLAVICLE PROCEDURE. THIS HAPPENED 1/2 TO 2/3 OF THE WAY INTO THE CASE. THE SURGEON STATED THAT THE CAUTERY PENCIL WAS TURNED OFF BUT THEN 'ARCHED' AND CAUSED THREE SMALL BURNS TO THE SKIN OF THE PT. THE SURGEON STATES IT DID NOT COME IN CONTACT WITH ANY METAL INSTRUMENT BUT ARCHED ON ITS OWN TO THE SKIN AND DENIES THAT IT WAS PLACED DOWN ON THE PT. THREE SMALL MINOR BURNS RESULTED. THEY WERE DESCRIBED AS TINY SPATULA SHAPED BURNS. NO MEDICAL OR SURGICAL INTERVENTION WAS INDICATED. THE PENCIL WAS RETURNED FOR EVAL. NO CAUTERY TIP WAS RETURNED. VISUAL EVAL AND OPERATIONAL TESTING WERE PERFORMED. VISUAL EVAL IDENTIFIED BLOOD STAINS AT THE BOTTOM PART OF THE PENCIL (CLOSE TO WHERE THE CAUTERY TIP SITS) AND ABOVE THE PENCIL BUTTONS. NO BLOOD STAIN ON THE BUTTONS. THE PENCIL WAS THEN PLUGGED INTO THE GENERATOR FOR OPERATIONAL TESTING. AS SOON AS THE GENERATOR WAS TURNED ON, IT TRIGGERED THE ALARM. IT WAS DETERMINED ONE OF THE PENCIL BUTTONS WAS STUCK AND STILL ACTIVE. THE PENCIL WAS TURNED OFF BY PUSHING BOTH BUTTONS. IT WAS NOT CLEAR WHICH BUTTON WAS ORIGINALLY ACTIVE. WE WERE UNABLE TO DUPLICATE THE ISSUE BY REPEATEDLY HOLDING THE BUTTONS FOR A PERIOD OF TIME. PENCIL WAS THEN TESTED BY CYCLING 10 TIMES IN BOTH CUT AND COAG MODES AT A SETTING OF 30. PENCIL PERFORMED NORMALLY IN BOTH MODES ON ALL CYCLES. THE TEST DID NOT TRIGGER THE ALARM. A ROOT CAUSE WAS NOT IDENTIFIED AND NO CORRECTIVE ACTION IS INDICATED AT THIS TIME. THE PENCIL IS BEING FORWARDED TO THE MANUFACTURER FOR FURTHER TESTING AND EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CAUTERY PENCIL WAS TURNED OFF BUT 'ARCHED' ON ITS OWN, CAUSING THREE SMALL BURNS ON THE SKIN OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY PENCIL PUSH BUTTON NONE GEI MEDLINE INDUSTRIES, INC. ESPB2000 080701334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other