BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 1651758 · Received March 31, 2010

    Report

    Report Number
    8020045-2010-00001
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 26, 2010
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    ODR
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THE INCIDENT AND THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN TESTED VISUALLY, ELECTRICALLY AND THERMALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES (THE DEVICE INVOLVED IN THE INCIDENT WAS IN AN STATE NOT SUITABLE FOR THE MECHANICAL TEST). ALL SAMPLES WERE FINE TO PERFORM WITHIN THE LIMITS. NO FAULTS COULD BE DETECTED. IT APPEARS THAT THE USER DID NOT FOLLOW THE IFU OF THE PRODUCT: WHEN A LOSS OF COAG WAS EFFECT WAS NOT CHECKED IMMEDIATELY BUT THE POWER INCREASED FROM 30 TO 40 (USER QUESTIONNAIRE AND USER INCIDENT REPORT TO (B) (6)). THE IFU SPECIFICALLY STATES "SHOULD (. . .) COAGULATION EFFECT DIMINISH DURING SURGERY (. . .) A PROBLEM MAY EXIST. IMMEDIATELY MAKE SURE THAT THE DISPERSIVE ELECTRODE [=GROUNDING PLATE] IS (. . .) IN FULL CONTACT WITH THE SKIN." THE ESCHMANN TD830 IS EQUIPPED WITH AN ELECTRODE CONTACT QUALITY 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 PLATE WOULD HAVE AVOIDED THE BURN. IMMEDIATELY CHECKING THE PLATE SITE WHEN THE LOSS OF THE COAGULATION EFFECT WAS DISCOVERED MIGHT HAVE REDUCED OR AVOIDED THE BURN. WE, THEREFORE, CONCLUDE THAT A USER ERROR, SPECIFICALLY NOT FOLLOWING THE IFU, AT LEAST CONTRIBUTED TO INCIDENT.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A 30 MINUTES VAGINAL HYSTERECTOMY WAS PERFORMED AT (B) (6) HOSPITAL, (B) (6). AN ESCHMANN TD 830 ELECTROSURGICAL GENERATOR AND A NON MONITORING DISPERSIVE ELECTRODE (MODEL WR01) WERE USED. THE ELECTRODE WAS PLACED ON THE UPPER RIGHT THIGH. THE PT WAS IN THE LITHOTOMY POSITION AND WAS NOT REPOSITIONED. THE PT IS NORMAL (B) (6) BUILT AND HAS A NORMAL DRY SKIN. THE SKIN WAS NOT CLEANED, NOT DISINFECTED AND NOT SHAVING. TOWARD THE END OF THE PROCEDURE, THE SURGEON NOTICED A LOSS IN COAGULATION EFFECT AND SHORTLY AFTERWARDS AN ALARM WENT OFF. IT WAS DISCOVERED THAT THE ELECTRODE HAD ALMOST ENTIRELY COME OFF. A LINE OF BLISTERS INCLUDING A THIRD DEGREE BURN OF APP 10 SQMM WAS DISCOVERED UNDERNEATH. ANOTHER ELECTRODE OF THE SAME LOT WAS APPLIED ON THE OTHER THIGH AND THE PROCEDURE WAS COMPLETED. ACCORDING TO THE INFO PROVIDED BY THE HOSPITAL THE BURN WAS NOT TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT ELECTROSURGICAL GROUNDING PLATE ODR LEONHARD LANG GMBH WR01 91127-0813

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other