BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 9658694 · Received February 3, 2020

    Report

    Report Number
    8020045-2020-00003
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    January 2, 2020
    Report Date
    February 3, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    19005531597379
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER HAS INDICATED TWO LOT NUMBERS 190426-2403 AND 190527-2404 AS THE POTENTIAL LOT OF THE INVOLVED ELECTRODE. RETAINED SAMPLES OF BOTH CONCERNED LOT NUMBERS WERE INSPECTED VISUALLY, ELECTRICALLY AND MECHANICALLY. ALL ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE FOR AN INVESTIGATION. ACCORDING TO THE USERS DESCRIPTION OF THE INCIDENT, THEY HAVE DEVIATED FROM THE IFU: THE IFU STATES THE PRECAUTION: "CHOOSE A MUSCULAR OR WELL VASCULARIZED CONVEX SKIN SITE AS CLOSE TO THE OPERATING FIELD AS POSSIBLE, BUT NOT CLOSER THAN 15 CM, ON ADULTS PREFERABLY AN UPPER ARM OR THIGH. MAKE SURE THE SITE WILL NOT BEAR THE PATIENT'S WEIGHT DURING SURGERY (...)." THE C-SECTION WAS PERFORMED ON THE PATIENTS LOWER ABDOMEN. HOWEVER, THE ELECTRODE WAS PLACED ON HER RIGHT CALF. THERE ARE LOCATIONS SUITABLE FOR PLACING THE ELECTRODE FAR CLOSER TO THE LOCATION OF SURGERY (E.G. ON FRONT SIDE OF THE RIGHT THIGH) THAN THE SITE CHOSEN. THE IFU FURTHER STATES "ALIGN A SPLIT NEUTRAL ELECTRODE IN SUCH A WAY THAT ITS SPLIT POINTS TOWARDS THE SURGICAL AREA AND THE CORD AWAY FROM IT." THE USER HAD PLACED THE SPLIT ELECTRODE POINTING SIDEWAYS AND NOT TOWARDS THE SURGICAL AREA. THE IFU STATES EXPLICITLY "IMPROPER USE OF NEUTRAL ELECTRODES CAN CAUSE PATIENT INJURIES. THESE INSTRUCTIONS SERVE PATIENT SAFETY. NOT FOLLOWING THESE INSTRUCTIONS MAY LEAD TO BURNS, PRESSURE NECROSES OR OTHER SKIN TRAUMA DURING USE." WE THEREFORE CONCLUDE THAT THE A USER ERROR CAUSED OR CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    ON JANUARY 09TH, 2020, WE HAVE BEEN INFORMED ABOUT A 55 MINUTES LSCS (LOWER SEGMENT CAESAREAN SECTION) SURGERY WAS PERFORMED AT AN HOSPITAL IN (B)(6). A MONITORING DISPERSIVE ELECTRODE (MODEL RS27A30) AND AN ERBE VIO 300S GENERATOR WERE USED. 48 HOURS AFTER THE SURGERY A SUPERFICIAL BURN WAS NOTED WHERE THE ELECTRODE HAD BEEN PLACED, CORRESPONDING TO A LOCATION UNDERNEATH THE EDGE OF THE DISPERSIVE ELECTRODE NEAR THE CABLE ACCORDING TO A DRAWING PROVIDED. WE HAVE RECEIVED A FILLED IN QUESTIONNAIRE. THE PATIENT WAS DESCRIBED AS SLIM AND THE GENERAL STATUS OF THE PATIENT WAS DESCRIBED AS NORMAL. THE SKIN TYPE WAS DESCRIBED AS NORMAL. THE SKIN WAS NOT CLEANED, NOT SHAVEN, NOT DISINFECTION AND NO OINTMENT HAD BEEN USED BEFORE APPLYING THE DISPERSIVE ELECTRODE. THE PATIENT WAS LYING IN SUPINE POSITION PLACED ON A WARMING BLANKET AT 37,2°C. THE INITIAL REPORTER STATED THAT DISPERSIVE ELECTRODE WAS PLACED AT THE LATERAL SIDE OF THE RIGHT CALF. A DRAWING PROVIDED WITH THE QUESTIONNAIRE SHOWS THE ELECTRODE PLACED ON THE BACK SIDE OF THE RIGHT CALF POINTING SIDEWAYS. THE GENERATOR OUTPUT WAS DESCRIBED AS 40 AND THE OUTPUT HAS NOT BEEN RAISED DURING SURGERY. THE PATIENT HAD NOT BEEN REPOSITIONED AND THE DISPERSIVE ELECTRODE WAS "PROPERLY ATTACHED." NO INFORMATION WAS PROVIDED IN THE QUESTIONNAIRE IF THE DISPERSIVE ELECTRODE HAD COME OFF. A PHOTO OF THE INJURY WAS PROVIDED. ON THE PHOTO A SECOND DEGREE BURN IS VISIBLE. BASED ON THE PICTURE, NO STATEMENT CAN BE MADE ABOUT THE SIZE OF THE INJURY. NO INFORMATION WAS PROVIDED IF AND HOW THE INJURY WAS TREATED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122698 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS27A30 190426-2403 19005531597379

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other