BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 6192540 · Received December 21, 2016

    Report

    Report Number
    8020045-2016-00027
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    September 21, 2016
    Report Date
    February 2, 2017
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 2 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE ARE NOT ENTIRELY SURE BUT WE ASSUME THAT A USER ERROR NOT RELATED TO THE DISPERSIVE ELECTRODE MIGHT HAVE LEAD TO THE INCIDENT. THIS ASSUMPTION IS BASED ON A REPORT OF A COMPANY REPRESENTATIVE, WHO HAS VISITED THE HOSPITAL IN JANUARY AND WAS ABLE TO DISCUSS THE MATTER WITH THE RESPONSIBLE SENIOR PHYSICIAN. IT TURNED OUT THAT THE SAME INCIDENT HAS OCCURRED WITH A DISPERSIVE ELECTRODE PROVIDED BY THE MANUFACTURER OF THE ELECTROSURGICAL GENERATOR. THE PHYSICIAN THUS CONSIDERS A USER ERROR AS THE POSSIBLE ROOT CAUSE FOR THE INCIDENT(S). BASED ON THE PROVIDED INFORMATION WE DO NO LONGER CONSIDER THE DISPERSIVE ELECTRODE CONTRIBUTIVE OR CAUSAL TO THE INCIDENT AND THEREFORE CLOSE THE INVESTIGATION. DEVICE WAS DISCARDED AFTER THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 2 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. IT IS UNCLEAR, IN WHAT WAY THE COMPLAINANT CONSIDERS THE DISPERSIVE ELECTRODE CONTRIBUTIVE OR CAUSAL TO THE INCIDENT. A SUDDEN CHANGE OF POWER MIGHT BE CAUSED BY A DISPERSIVE ELECTRODE LOSING CONTACT TO THE SKIN. THIS HAS NOT BEEN REPORTED TO US AND NO BURN WAS DETECTED UNDERNEATH THE ELECTRODE (WHICH ALSO COULD BE A CONSEQUENCE OF AN ELECTRODE NOT STICKING PROPERLY). HOWEVER, THERE ARE OTHER POTENTIAL CAUSES FOR LOSS OR REDUCTION OF POWER NOT ASSOCIATED WITH A DISPERSIVE ELECTRODE. AS NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO US DESPITE OF REPEATED EFFORTS (QUESTIONNAIRE, REPEATED EMAILS), NO FURTHER CONCLUSION CAN BE DRAWN AT THIS STAGE. WE HAVE BEEN TRYING TO SET UP A VISIT OF A PRODUCT SPECIALIST TO THE COMPLAINING USER FACILITY BUT HAVE NOT YET BEEN GIVEN A DATE FOR SUCH A VISIT. WE WILL REPORT ANY FURTHER RESULTS OF OUR INVESTIGATION IN A FOLLOW-UP REPORT. DEVICE WAS DISCARDED AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, WE HAVE BEEN INFORMED ABOUT AN INCIDENT DURING AN ELECTROSURGICAL PROCEDURE (PAPILLOTOMY) IN (B)(6). AN ERBE GENERATOR AND A SKINTACT DISPERSIVE ELECTRODE WR21 WERE USED. THE ELECTRODE WAS PLACED ON THE BACKSIDE OF THE LEFT THIGH. THE PATIENT WAS LYING IN PRONE POSITION AND WAS NOT REPOSITIONED. THE BODY TYPE OF THE PATIENT WAS DESCRIBED AS NORMAL AND THE SKIN AS NORMAL. THE PATIENT SKIN WAS NOT CLEANED, NOT SHAVEN, NOT DRIED AND NOT DISINFECTED. NO OINTMENT HAD BEEN APPLIED. THE POWER SETTING WAS DESCRIBED AS "STANDARD PAPILLOTOMY MONOPOLAR SOCKET FORCED 60W" AND WAS NOT RAISED. THE HOSPTIAL STATED THAT THE DISPERSIVE ELECTRODE ADHERED WELL TO THE PATIENT. THE PATIENT FELT PAIN AND SUFFERED FROM TWITCHING MUSCULAR CONTRACTIONS DURING THE INTERVENTION. THE REPORTER STATED THAT AN UNCONTROLLED INCISION AND AN UNCONTROLLED APPLICATION OF POWER OCCURRED. SHE SUFFERED NO BURNS. THE INVOLVED DISPERSIVE ELECTRODE WAS DISCARDED AFTER THE PROCEDURE. FORTY EIGHT HOURS AFTERWARDS AN ABDOMINAL CT IMAGING PROCEDURE WAS PERFORMED. A RETROPERITONEAL PERFORATION OF THE DUODENUM WAS DISCOVERED. IT WAS REPORTED THAT NO DAMAGE OF THE SKIN WAS NOTABLE AND NO MEDICAL TREATMENT WAS NECESSARY.

    Description of Event or Problem · 1

    ON NOVEMBER 21TH, 2016, WE HAVE BEEN INFORMED ABOUT AN INCIDENT DURING AN ELECTRO SURGICAL PROCEDURE (PAPILLOTOMY) IN (B)(6). AN ERBE GENERATOR AND A SKINTACT DISPERSIVE ELECTRODE WR21 WERE USED. THE REPORTER STATED THAT AN UNCONTROLLED INCISION AND AN UNCONTROLLED APPLICATION OF POWER OCCURRED. THE PATIENT FELT PAIN AND SUFFERED FROM TWITCHING MUSCULAR CONTRACTIONS. SHE SUFFERED NO BURNS. THE INVOLVED DISPERSIVE ELECTRODE WAS DISCARDED AFTER THE PROCEDURE. NO INFORMATION ABOUT THE PRECISE PLACEMENT SITE OF THE ELECTRODE ON THE SKIN, HOW THE SKIN WAS PREPARED, THE GENERATOR MODEL, THE POWER SETTINGS, THE NATURE OF THE UNCONTROLLED POWER APPLICATION, WHETHER THE ELECTRODE ADHERED WELL TO THE SKIN AND THE NATURE OF THE PAIN THE PATIENT FELT HAVE BEEN DISCLOSED TO US YET DESPITE OF REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842789 SKINTACT WR21 GEI LEONHARD LANG GMBH SKINTACT 60517-0804

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other