BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIT DISPERSIVE ELECTRODE

    MDR report key: 1903843 · Received November 20, 2010

    Report

    Report Number
    1720159-2010-00072
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL HAVE NOT RELEASED THE DEVICE FOR INVESTIGATION BY THE MANUFACTURER. IT IS BELIEVED TO BE AT (B)(6). (B)(6) AGREED TO ALLOW AN INDEPENDENT BIOMEDICAL ENGINEER (B)(6) TO REVIEW THE VALLEYLAB FORCE 2 ELECTROSURGICAL UNIT, VALLEYLAB REM, CONMED DISPERSIVE ELECTRODE AND OTHER ACCESSORIES IN USE AT THE TIME. (B)(6) INSPECTED AND TESTED THE RELEVANT EQUIPMENT ON 11NOV2010 IN ACCORDANCE WITH (B)(4). THE ESU WAS TESTED AT THE SETTINGS REPORTED BY STAFF AT THE TIME OF THE INCIDENT AND AT MAXIMUM POWER IN ALL MODES FOR ACCURACY OF POWER OUTPUT AND RF LEAKAGE CURRENTS, INCLUDING THERMAL EFFECTS OF HF LEAKAGE CURRENTS (TESTING INCLUDED GENERAL INSPECTION,MAINS SUPPLY CONDUCTORS, SUSPENDED MASSES, PERFORMANCE TESTING AND OTHER FUNCTIONAL TESTS). THE REM CIRCUIT WAS TESTED IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS AND FOUND TO BE ACCURATE AND OPERATING CORRECTLY. REM ALARMS WERE TESTED AND FOUND CORRECT. NON REM CIRCUIT WAS TESTED AND FOUND OPERATING CORRECTLY. ALSO TESTED WERE ACCESSORIES IN USE AT THE TIME, INCLUDING THE PATIENT ELECTRODE (PLATE) (INSULATION FOUND SATISFACTORY BETWEEN ELECTRODES), OTHER 410-2200 DISPERSIVE ELECTRODES FROM THE SAME LOT (ALSO FOUND SATISFACTORY FOR INSULATION) AND RETURN ELECTRODE CABLE. ALL TEST RESULTS WERE REPORTED TO BE WELL WITHIN LIMITS OF SAFETY AS PER THE STATED STANDARDS. THE USER REPORTED THAT THE DIATHERMY PLATE APPEARED TO HAVE FULL CONTACT, WITH THE EXCEPTION OF A SMALL CREASE IN THE PLATE POSSIBLY CAUSED BY REPOSITIONING THE PATIENT'S LEG. THE DIRECTIONS FOR USE / WARNINGS SUPPLIED WITH THE (B)(4) STATES: FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE ADHESIVE SURFACE MAY RESULT IN AN ELECTROSURGICAL BURN OR POOR ELECTROSURGICAL PERFORMANCE. IF PATIENT IS REPOSITIONED DURING PROCEDURE, RE-INSPECT THE DISPERSIVE ELECTRODE AND ALL CONNECTIONS. THE BURN WAS INITIALLY REPORTED TO APPEAR SUPERFICIAL, SKIN INTACT. IT WAS LATER REPORTED TO BE A "VERY SMALL 3RD DEGREE BURN". NO CORRECTIVE ACTION WAS REPORTED NECESSARY, AND IT IS UNDERSTOOD IT WILL HEAL WITHOUT NEED FOR FURTHER TREATMENT.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GYNAE PROCEDURE, THE SURGEON WAS USING A VALLEYLAB FORCE 2 ELECTROSURGICAL UNIT TOGETHER WITH A VALLEYLAB REM, CONTACT QUALITY MONITORING SYSTEM (TO REDUCE THE RISK OF BURNS UNDER THE PATIENT RETURN ELECTRODE). DURING THE PROCEDURE, THE REM ALARMED FOR A SECOND AND THEN STOPPED (IT IS UNDERSTOOD THIS MAY HAVE BEEN WHEN THE PATIENT WAS REPOSITIONED). HOWEVER, NO PROBLEM WAS FOUND. THE FACILITY REPORTED THAT THE SURGEON "DID NOT FEEL IT THE ELECTROSURGICAL UNIT] WAS WORKING PROPERLY", SO (B)(6) CHECKED THE MACHINE SETTINGS AND CHANGED THE INSTRUMENT LEADS (INCLUDING THE REM LEAD). IT WAS REPORTED THAT THE DIATHERMY PLATE APPEARED TO HAVE FULL CONTACT, WITH THE EXCEPTION OF A SMALL CREASE IN THE PLATE POSSIBLY CAUSED BY REPOSITIONING THE PATIENT'S LEG. WHEN THE PLATE WAS FINALLY REMOVED, AN OBVIOUS SMELL OF BURNING WAS NOTED AND A SMALL, SUPERFICIAL, BLACKENED AREA ON THE PATIENT'S SKIN (APPROX. 1CM) - CORRESPONDING TO A BLACKENED AREA ON THE PLATE, WAS NOTED. THE SKIN WAS SUBSEQUENTLY REPORTED AS BEING INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIT DISPERSIVE ELECTRODE DISPERSIVE ELECTRODE / GROUNDING PAD GEI CONMED ELECTROSURGERY 1007025

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other VALLEYLAB RETURN ELECTRODE CABLE| VALLEYLAB REM (REMOTE ELECTRODE MONITORING) SYSTEM| VALLEY FORCE 2 ESU (B)(4)| VALLEYLAB ACTIVE ACCESSORIES