BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIMB PK (LAFHE)317

    MDR report key: 983100 · Received January 17, 2008

    Report

    Report Number
    1423507-2008-00006
    Event Type
    Other
    Date Received
    January 17, 2008
    Date of Event
    November 8, 2007
    Report Date
    January 17, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR OF THE PUSH-BUTTON, CAUTERY PENCIL WITH HOLSTER (COMPONENT G-2516H-NS LOT 763536), MODERN MEDICAL EQUIPMENT MFG, LTD STATED INITIALLY IN NOVEMBER 2007 AND AGAIN IN JANUARY 2008 THEY WOULD FILE AN MDR ON THIS ISSUE. ON JANUARY 17, 2008 CARDINAL HEALTH WAS INFORMED MODERN MEDICAL EQUIPMENT MFG, LTD HAS NOW DECLINED TO FILE AN MDR. CARDINAL HEALTH IS THEREFORE FILING THE REPORT AS THE CONVENIENCE KIT COMPLIER. SAMPLE WAS RETURNED DIRECTLY FROM CUSTOMER TO VENDOR. PER THE INVESTIGATION RESULTS RECEIVED FROM THE VENDOR: THEY RECHECKED THE RETURNED SAMPLE BY VISUAL INSPECTION. THERE IS NO BLOODSTAIN ON THE PENCIL. A YELLOW STAIN IS FOUND ON THE BACKSIDE OF THE PENCIL. THEY ESTIMATED THE RETURN SAMPLE HAD BEEN CLEANED BEFORE RETURN TO THEM. WHEN PLUGGING THE SAMPLE INTO THE GENERATOR, THERE IS NOT ANY AUTOMATIC ACTIVATION FOUND IN THE OPEN CONDITION OF THE PENCIL. DURING 200 CYCLES OF DEPRESS AND RELEASE THE CUT AND COAG BUTTONS, EVERYTHING IS IN NORMAL CONDITION. EVERY TIME THEY DEPRESSED THE BUTTON, THERE IS A SHARP AND CLEAR ACTIVATION ALARM TURNING ON IMMEDIATELY. THE ALARM GOES OFF WITH RELEASE OF THE BUTTON. ELASTICITY TEST OF THE COAG BUTTON SHOWED NO ABNORMALITIES. THE VENDOR ESTIMATES DRIED BLOOD JAMMING DURING OPERATION MAY CAUSE THIS ISSUE. BASED ON THE ABOVE INVESTIGATION, THEY WERE UNABLE TO CONFIRM THIS FAILURE. AS A CORRECTIVE ACTION: ADD'L EMERGENCY INSPECTION INSTRUCTION FOR CHECKING THE JAMMING OF THE BUTTON AND CONTINUITY OF THE PENCIL. ADD'L CHECK POINT WILL BE EXECUTED FOR 100% CHECK THIS FEATURE ACCORDING TO THE UPDATING INSPECTION INSTRUCTION UNTIL THE LONG TERM CORRECTIVE ACTION HAVE BEEN PLANNED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE CAUTERY PUSH BUTTON PENCIL, WHERE THE COAGULATION BUTTON JAMMED. THIS INCIDENT RESULTED IN A SMALL - 3MM BURN ON THE END OF THE PT'S RIGHT THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMB PK (LAFHE)317 LIMB PACK GEI CARDINAL HEALTH SOP30LAFHF 797152

    Patients

    Seq Age Sex Outcome Treatment
    1