BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    568802 MAX ASE VL TERM 1P25B50

    MDR report key: 1844595 · Received September 20, 2010

    Report

    Report Number
    1219103-2010-00010
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SAMPLES WERE NOT RETURNED FOR EVAL; HOWEVER, TWO PHOTOGRAPHS OF A SINGLE GROUNDING PAD WERE PROVIDED WITH A COPY OF THE OLYMPUS SURGMASTER UES-40 ELECTROSURGICAL UNIT INSTRUCTION MANUAL. THE PHOTOGRAPHS SHOW WHAT SEEMS TO BE THE SAME GROUNDING PAD. THE FIRST PHOTO SHOWS THE ENTIRE GROUNDING PAD LYING ON TOP OF ITS COILED WIRES. IN THE PICTURE, THE GEL SIDE OF THE GROUNDING PAD IS FACING THE VIEWER AND THE TERMINAL COVER IS POSITIONED AT THE TOP OF THE PHOTO. THE BOTTOM RIGHT CORNER OF THE ELECTRODE APPEARS TO HAVE A BLACKENED AREA WHICH COVERS APPROX 4.5% OF THE ENTIRE ELECTRODE SURFACE. THE BLACKENED MARK IS PARTIALLY IN THE TIN/HYDROGEL AREA OF THE ELECTRODE AND PARTIALLY IN THE FOAM/ADHESIVE AREA (ABOUT 50/50). THE ELECTRODE IN THE PHOTO ALSO SEEMS TO HAVE SOME FOREIGN MATERIAL ON THE FOAM/ADHESIVE PERIPHERY OF THE ELECTRODE (FOUR PIECES ON THE LEFT EDGE AND FIVE OR SIX PIECES ON THE BOTTOM EDGE). THE SECOND IMAGE SHOWS A CLOSE-UP OF THE BLACKENED CORNER OF THE ELECTRODE. IN THIS IMAGE, IT APPEARS THAT THE TIN LAYER, UPON WHICH THE HYDROGEL IS COATED, HAS LIFTED SLIGHTLY FROM THE FOAM/ADHESIVE LAYER. THE LIFTING OF THE TIN/GEL LAYER MAY HAVE RESULTED FROM PRODUCT DAMAGE DURING THE INCIDENT. THE FOREIGN MATERIAL IS LIKELY DUE TO THE HANDLING OF THE PRODUCT AFTER THE INCIDENT. THE LOT NUMBER FOR THIS COMPLAINT WAS PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED IDENTIFYING NO ABNORMALITIES. PRIOR TO A LOT'S RELEASE, IT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS BASED ON A VALID SAMPLING PLAN. A COMPLAINT HISTORY SEARCH FOR THIS PRODUCT AND COMPLAINT CODE WAS COMPLETED IN THE COMPLAINT TRACKING SYSTEM (CTS) REVEALING NO PRIOR COMPLAINTS OF THIS NATURE DURING THE PAST TWO YEARS. BASED ON THE DHR REVIEW AND THE REVIEW OF THE CUSTOMER SUPPLIED INFO, THE PATIENT BURN WAS LIKELY THE RESULT OF IMPROPER APPLICATION OF THE GROUNDING PAD OR PT MOVEMENT AFTER APPLICATION OF THE ELECTRODE. IN ADDITION, IT WAS REPORTED THAT THE PT WAS MOVED AFTER APPLICATION OF THE ELECTRODE AS WELL AS THE GROUNDING PAD WAS FOLDED BACK AT CORNER. THE INSTRUCTION MANUAL FOR THE ELECTROSURGICAL UNIT STATES THAT "WHEN THE PATIENT IS MOVED AFTER THE DISPERSIVE ELECTRODE HAS BEEN ATTACHED, CONFIRM THAT THE DISPERSIVE ELECTRODE IS STILL IN PROPER CONTACT WITH THE PT. OTHERWISE, IT MAY CAUSE PT AND/OR OPERATOR BURNS." HOWEVER, THERE IS NO CONFIRMATION THAT THIS STATEMENT FROM THE INSTRUCTION MANUAL WAS PERFORMED. THE INSTRUCTION MANUAL FURTHER STATES THAT "IMPROPER CONNECTION BETWEEN THE PT PLATE AND THE PT'S SKIN SURFACE MAY CAUSE BURNS. DO NOT FOLD OR WRINKLE THE PT PLATE. ITS ENTIRE SURFACE SHOULD BE IN DIRECT CONTACT WITH THE PT'S SKIN." IT IS, THEREFORE, LIKELY THAT THE GROUNDING PAD WAS DISTURBED AND NOT PROPERLY ADHERED TO THE PT'S SKIN AFTER PT MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6)2010 THAT A CUSTOMER HAD AN ISSUE WITH A DISPERSIVE ELECTRODE. THE CUSTOMER STATES THAT THE ELECTRODE FOLDED OVER WHILE THE PATIENT WAS BEING MOVED DURING A PROCEDURE, AND THE PATIENT RECEIVED POSSIBLE THIRD DEGREE BURNS AS A RESULT. THE PT WAS TREATED WITH SILVERDENE CREAM 1%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 568802 MAX ASE VL TERM 1P25B50 DISPERSIVE ELECTRODE GEI COVIDIEN PG91086 914905

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other