BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 2151532 · Received July 5, 2011

    Report

    Report Number
    8020045-2011-00004
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    May 16, 2010
    Report Date
    June 17, 2011
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K030362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT WAS RETURNED STUCK ONTO A PLASTIC FOIL OF A SMALL BAG. THE DEVICE INVOLVED, SAMPLES RETURNED BY THE CUSTOMER AND RETAINED SAMPLES OF THE SAME LOT HAVE BEEN TESTED VISUALLY, ELECTRICALLY, AND THERMALLY. MECHANICAL TESTS WERE PERFORMED ON ONE CUSTOMER SAMPLE AND TWO RETAINED SAMPLES (THE DEVICE INVOLVED IN THE INCIDENT WAS IN A STATE NOT SUITABLE FOR THE MECHANICAL TEST). ALL DEVICES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE IFU STATES "CHOOSE A MUSCULAR OR WELL VASCULARIZED CONVEX SKIN SITE, (...). AVOID (...) BONE PROMINENCES". THE BACKSIDE OF THE KNEE IS NOT NECESSARILY SUCH A SITE. GUESSING THE DIAMETER OF A 5 KG BABY'S LEG IT IS ALSO HARDLY IMAGINABLE THAT THE HOSP FOLLOWED ANOTHER SEGMENT OF THE IFU, SPECIFICALLY "WHEN WRAPPING THE ELECTRODE AROUND A LIMB, THE ELECTRODE MUST NOT TOUCH OR OVERLAP ITSELF." A WARNING IN THE IFU STATES "USE THIS INFANT DISPERSIVE ELECTRODE AT POWER SETTINGS UP TO 150 WATT." THE HOSP HAS STATED THE POWER SETTING FOR CUTTING WAS 300 WATT. WE, THEREFORE, CONCLUDE THAT A USER ERROR CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6), 2011, AT HOSPITAL (B)(6), A 6 HRS HEPATIC TRANSPLANT WAS PERFORMED ON A BABY. A VALLEY LAB FORCE2 ELECTROSURGICAL GENERATOR AND A SKINTACT MONITORING DISPERSIVE ELECTRODE (MODEL RS22) WERE USED. THE ELECTRODE WAS PLACED ON THE BACKSIDE OF THE RIGHT KNEE. THE PT WAS LYING IN SUPINE POSITION AND WAS NOT REPOSITIONED. THE PT WAS DESCRIBED AS SLIM. HER SKIN TYPE WAS DESCRIBED AS "NORMAL THIN". THE SKIN WAS NOT CLEANED, NOT DISINFECTED AND NO OINTMENT HAD BEEN APPLIED. THE SKIN WAS DRIED. THE POWER SETTING WAS DESCRIBED AS 300W FOR CUTTING AND 120W FOR COAGULATING. THE HOSP STATED THAT THE PLATE WAS ADHERING WELL. NO CONTACT QUALITY MONITORING ALARM SOUNDED DURING THE PROCEDURE. AFTER THE PROCEDURE "A HYPEREMIA AND WOUND WAS NOTICED WHILST REMOVING" THE DISPERSIVE ELECTRODE. THE WOUND HAS BEEN DESCRIBED AS "ROUND WOUND AROUND 2.5MM". THE WOUND HAD BEEN TREATED BY PLASTER/DRESSING GROUP AND IS EVALUATED DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS22 91211-0827

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention