BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR, VULCAN CE

    MDR report key: 4100007 · Received September 18, 2014

    Report

    Report Number
    1643264-2014-00022
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    PMA / PMN Number
    K991140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ONE VULCAN GENERATOR WAS RECEIVED AND CONFIRMED TO BE SERIAL NUMBER (B)(4). NO OTHER ACCESSORIES SUCH AS A FOOTSWITCH, PROBE, OR GROUND PAD WERE RETURNED. A DOCUMENT REVIEW SHOWS THAT THIS UNIT HAS BEEN IN SERVICE SINCE JUNE OF 2002 AND HAS NO DOCUMENTED FACTORY SERVICE HISTORY. THE UNIT WAS VISUALLY INSPECTED AND APPEARS TO BE IN AVERAGE CONDITION. NO INTERNAL OR EXTERNAL DAMAGE WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED USING A STANDARD TEST BENCH THAT IS EQUIPPED WITH ALL NECESSARY SYSTEM ACCESSORIES. NO PROBLEMS WERE FOUND. UNIT PASSED ALL ACCEPTANCE CRITERIA SET FORTH IN MANUFACTURING PROCESS SUMMARY, SAFETY AND FUNCTIONAL TESTING. THE PROPER PLACEMENT OF THE GROUND PAD IS ESSENTIAL AS RADIO FREQUENCY (RF) CURRENT CONCENTRATION CAN BUILD UP UNDER THE SPLIT ELECTRODE GROUND PAD WHEN IT IS PLACED OVER POORLY CONDUCTIVE TISSUE AND CREATES A POTENTIAL FOR BURNS. POOR SKIN CONTACT CAN INHIBIT THE CURRENT FLOW TO THE PAD AND CAUSE HIGHER CURRENT CONCENTRATION IN THE AREAS OF THE PAD THAT DO CONTACT THE PATIENT. RECOMMENDATIONS FOR GROUND PAD PLACEMENT CAN BE FOUND IN THE INSTRUCTIONS FOR USE AND SUPPLEMENTAL DOCUMENT (B)(4). A REVIEW OF RELEVANT CLINICAL/MEDICAL INFORMATION IN THE REPORTED ISSUE HAS CONCLUDED THAT A USER ERROR CANNOT BE EXCLUDED BASED ON THE INFORMATION PROVIDED. THIS MODEL VULCAN GENERATOR IS OBSOLETE AND IS NO LONGER SERVICED BY SMITH & NEPHEW. THIS UNIT WILL NOT BE RETURNED TO THE FIELD. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO THE MANUFACTURER. THE DEVICE EVALUATION IS ONGOING. (B)(4).

    Description of Event or Problem · 1

    DURING AN ACL RECONSTRUCTION IT WAS REPORTED THE SURGEON USED A RF PROBE WITH THE VULCAN GENERATOR. IT WAS REPORTED THEY WERE ABLE TO HEAR THE SOUND OF THE PROBE LIKE IT WAS FUNCTIONING NORMALLY AND THERE WAS NO ERROR MESSAGE ON THE CONSOLE. HOWEVER, THE PROBE INSIDE THE JOINT DID NOT WORK PROPERLY. THE INTENSITY WAS INCREASED AND STILL NOT WORKING PROPERLY. THE SURGEON REPORTED A SMELL OF BURNING. THE PROBE WAS CHANGED BECAUSE IT WAS BELIEVED TO BE FAULTY. A NEW PROBE PRODUCED THE SAME RESULT. NEXT A SECOND VULCAN WAS USED WITH THE SAME PROBE. AS SOON AS THE PROBE WAS ATTACHED TO THE NEW MACHINE THE ERROR MESSAGE CAME ON THAT THERE WAS A PROBLEM WITH THE PAD. THE NURSE CHECKED THE CONMED PAD THAT WAS PLACED ON THE RIGHT THIGH (LEG), HOWEVER IT WAS NOT PROPERLY IN PLACE. A PORTION OF THE PAD WAS OVER THE GOWN OF THE PATIENT AND THE PAD WAS BURNED AT THAT SPOT. THE PAD HAD BEEN INSTALLED BY THE RESIDENT. UPON FOLLOW UP THE PLASTIC SURGEON ON SITE REPORTED THE BURN TO BE A SECOND OR THIRD DEGREE BURN. THE WOUND WAS CLEANED AND SOME ANTIBIOTIC APPLIED BY THE PLASTIC SURGEON. IT WAS REPORTED THE PATIENT WAS FINE DURING A SCHEDULED VISIT WITH THE PLASTIC SURGEON 3 DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577762 GENERATOR, VULCAN CE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SMITH & NEPHEW, INC. 7209673 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention