BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 1735698 · Received June 24, 2010

    Report

    Report Number
    8020045-2010-00009
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 11, 2010
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY, THERMALLY AND MECHANICALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. AN ANALYSIS OF THE INFORMATION PROVIDED BY THE HOSPITAL INDICATES THAT THE BURN HAS BEEN CAUSED BY A USER ERROR, SPECIFICALLY BY NOT FOLLOWING THE INSTRUCTIONS FOR USE: THE IFU EXPLICITLY STATES A WARNING "IF AN ELECTROSURGICAL UNIT OFFERS AN ELECTRODE CONTACT QUALITY MONITORING SYSTEM (LIKE REM, NESSY ETC.), ALWAYS USE A SPLIT ELECTRODE." THE MARTIN ME 402 MAXIUM OFFERS SUCH A MONITORING SYSTEM. THE HOSPITAL HAS USED A NON-SPLIT ELECTRODE. THE USE OF A SPLIT ELECTRODE (INSTEAD THE NON-SPLIT ELECTRODE ACTUALLY USED) WITH ACTIVATED ELECTRODE CONTACT QUALITY MONITORING SYSTEM WOULD HAVE PREVENTED ANY BURN. THE IFU EXPLICITLY STATES A CAUTION "SHOULD CUTTING OR COAGULATING EFFECT DIMINISH DURING SURGERY OR A HIGHER THAN NORMAL POWER SETTING BE REQUESTED, A PROBLEM MAY EXIST. IMMEDIATELY MAKE SURE THAT THE DISPERSIVE ELECTRODE IS ADEQUATELY PLACED AND IN FULL CONTACT WITH THE SKIN (...) BEFORE TURNING UP POWER!" THE USER INCREASED POWER BEFORE CHECKING THE ELECTRODE. THE IFU EXPLICITLY STATES "(...) MAKE SURE THE SITE WILL NOT BEAR THE PATIENT'S WEIGHT DURING SURGERY OR BE SUBJECT TO OTHER PRESSURE." THE HOSPITAL REPORTED THAT AN ELASTIC SOCK COVERED THE PATIENT'S LEG AND THE PLATE. AN ELASTIC SOCK SUBJECTS THE ELECTRODE AND THE TISSUE UNDERNEATH TO PRESSURE AND THUS, IMPEDES PROPER HEAT DISSIPATION. WE, THEREFORE, CONCLUDE THAT USER ERRORS CAUSED THE EVENT.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A 2 HOURS LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS PERFORMED ON A (B) (6) WOMAN AT (B) (6) HOSPITAL, (B) (6). A MARTIN ME 402 MAXIUM (B) (4) ELECTROSURGICAL GENERATOR AND A NON-MONITORING DISPERSIVE ELECTRODE (MODEL RS05) WERE USED. THE ELECTRODE WAS PLACED ON THE LEFT THIGH. THE PATIENT WAS PLACED ON HER BACK IN ANTI-TRENDELENBURG POSITION AND WAS NOT REPOSITIONED. THE SKIN TYPE OF THE PATIENT WAS DESCRIBED AS NORMAL. THE SKIN WAS SHAVEN, CLEANED WITH A PHYSIOLOGICAL SOLUTION, NOT DISINFECTED BUT DRIED. THE HOSPITAL STATED, THE ESU GENERATOR WAS USED WITH A DISSECTOR AND THE GENERATOR WORKED PROPERLY, BUT UPON USING A FORCEPS THE COAGULATING EFFECT WAS VERY POOR. THE HOSPITAL TOOK SEVERAL STEPS SUCH AS A POWER INCREASE WITHOUT IMPROVING THE SITUATION. AFTER THAT THE DISPERSIVE ELECTRODE WAS CHECKED AND 2 DEEP BURNS (THIRD DEGREE) WERE DISCOVERED UNDERNEATH THE ELECTRODE. THE SURGICAL PROCEDURE WAS CONTINUED REPLACING THE ELECTRODE AND THE GENERATOR. THE WOUND HAS BEEN TREATED WITH SPECIFIC MEDICAL INTERVENTION. NEITHER THE SIZE OF THE WOUNDS, THEIR PRECISE POSITION ON THE ELECTRODE NOR THE ORIENTATION OF THE ELECTRODE ON THE BODY HAVE BEEN DISCLOSED TO US YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS05 00118-0824

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other