BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 2473788 · Received February 23, 2012

    Report

    Report Number
    8020045-2012-00003
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    December 30, 2011
    Report Date
    February 23, 2012
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY, TESTED ELECTRICALLY AND THERMALLY. MECHANICAL TEST WERE PERFORMED ON 2 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE IFU SPECIFICALLY STATES "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 NEUTRAL ELECTRODE IS ADEQUATELY PLACED AND IN FULL CONTACT WITH THE SKIN. INSPECT ALL CONNECTIONS OF THE NEUTRAL ELECTRODE I.E. CLAMP, CABLE, CONNECTOR PLUS ALL ACTIVE ACCESSORIES AND THE GENERATOR BEFORE TURNING UP POWER." THE WEM SS500 IS EQUIPPED WITH AN ELECTRODE CONTRACT QUALITY MONITORING SYSTEM (PPM - PATIENT-PLATE MONITORING SYSTEM), WHICH ONLY WORKS WITH A MONITORING ELECTRODE ("SPLIT"). AN UNSPLIT NON-MONITORING ELECTRODE WAS USED. THE IFU SPECIFICALLY STATES "IF AN ELECTROSURGICAL UNIT OFFERS AN ELECTRODE CQMS (...) ALWAYS USE A SPLIT ELECTRODE." THE USE OF A SPLIT ELECTRODE COULD HAVE AVOIDED THE BURN. WE, THEREFORE, CONCLUDE THAT A USER ERROR, SPECIFICALLY NOT FOLLOWING THE IFU, HAS CAUSED OR CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AT HOSPITAL (B)(6), A 40 MINUTES DRAINAGE OF ABSCESS ANU-RECTAL PROCEDURE WAS PERFORMED ON THE PT. A WEM (MODEL SS500) ELECTROSURGICAL GENERATOR AND A SKINTACT DISPERSIVE ELECTRODE (MODEL RO01) WERE USED. THE ELECTRODE WAS PLACED ON THE FRONTSIDE OF THE LEFT THIGH. THE PT WAS LYING IN A GYNECOLOGICAL POSITION AND WAS NOT REPOSITIONED. THE BODY TYPE OF THE PT WAS DESCRIBED AS THIN AND THE SKIN AS NORMAL. THE SKIN WAS SHAVEN, NOT CLEANED, NOT DISINFECTED, NOT DRIED AND NO OINTMENT HAD BEEN APPLIED. THE POWER SETTING WAS DESCRIBED AS "30 COAGULATION AND 30 CUTS". THE HOSPITAL STATED THAT THE PLATE WAS COMING OFF AT A RELATIVE AREA TO THE TOTAL AREA OF 20%. IT WAS ALSO REPORTED THAT THE POWER SETTING WAS INCREASED DURING SURGERY " (...) 50 CUTS UND COAGULATION". AFTER THE PROCEDURE, A BURN WAS NOTICED IN THE CENTER OF THE ELECTRODE. THE WOUND HAS BEEN DESCRIBED AS A "1,5CM X 1,5CM OVAL SHAPED" 2ND AND 3RD DEGREE BURN. THE WOUND HAS BEEN TREATED WITH SUTURATION. NO INFO ON THE MEDICATION HAS BEEN AVAILABLE TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RO01 01105-0826

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other