BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFMED

    MDR report key: 1080384 · Received July 22, 2008

    Report

    Report Number
    8020045-2008-00007
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    April 2, 2008
    Report Date
    July 18, 2008
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    ODR
    PMA / PMN Number
    K030362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE INVOLVED HAS NOT BEEN AVAILABLE, ONLY THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN TESTED THERMALLY, ELECTRICALLY, FOR THEIR ADHESION AND INSPECTED VISUALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN THE LIMITS AND NO FAULTS COULD BE DETECTED. THE PHOTOS OF THE INJURY HAVE BEEN RECEIVED AND SHOW SIX BURN SPOTS. THESE BURNS ARE SPREAD OVER THE WHOLE AREA WHERE THE ELECTROSURGICAL PLATE HAD BEEN POSITIONED. ACCORDING TO THE BURN MARKS AND THE DRAWING IN THE RETURNED QUESTIONNAIRE, THE GROUNDING PLATE SEEMS TO HAVE BEEN POSITIONED CORRECTLY FOR THE SURGERY. BASED ON THE INFO AVAILABLE FROM THE USER AND FROM TESTS PERFORMED ON RETAINED SAMPLES, NO CONCLUSION REGARDING THE CAUSE OF THE INJURY CAN BE DRAWN.

    Description of Event or Problem · 1

    IN 2008, A TWO HOUR ELECTROSURGICAL PROCEDURE WAS PERFORMED ON THE UTERUS OF A PT OF NORMAL SKIN TYPE. A CONMED ELECTROSURGICAL GENERATOR (THE EXACT MODEL HAS NOT BEEN REVEALED) AND AN UNSPLIT GROUNDING PLATE WERE USED. THE GENERATOR'S POWER OUTPUT HAD BEEN SET TO LOW POWER AND HAD NOT BEEN RAISED. THE PT WAS NOT MOVED DURING THE PROCEDURE. THE SKIN WAS SHAVED, CLEANED WITH ALCOHOL AND DRIED. THE GROUNDING PLATE WAS REPORTED TO HAVE ADHERED WELL, NO RESIDUES OF GEL WERE OBSERVED ON THE SKIN UPON THE REMOVAL OF THE ELECTRODE. THE ELECTRODE HAD BEEN APPLIED HIGH ON THE LEFT THIGH. AFTER SURGERY VARIOUS BURNS WERE DISCOVERED UNDER THE GROUNDING PLATE. PHOTOS PROVIDED SHOW AT LEAST SIX INDIVIDUAL BURN MARKS AT VARIOUS LOCATIONS. THE INJURY WAS PHARMACEUTICALLY ("PHARMACOLOGICALLY") TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFMED GROUNDING PLATE ODR LEONHARD LANG GMBH RS08 80331-0808

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other