BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 18855357 · Received March 7, 2024

    Report

    Report Number
    9610614-2024-00019
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 7, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ESU WAS RETURNED AND INSPECTED/TESTED (NOTE: SINCE THE NEUTRAL ELECTRODE WAS FROM ANOTHER MANUFACTURER, IT WAS NOT AVAILABLE FOR AN EVALUATION BY ERBE. THEREFORE, AN ASSESSMENT OF THE ACCESSORIES' SAFETY AND FUNCTIONALITY IS UNKNOWN TO US.). THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. THE GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY (NOTE: AN EVALUATION OF THE ESU'S CHRONOLOGICAL DATA REVEALED THAT DURING PROCEDURE THE UNIT DISPLAYED SYMMETRY WARNINGS REGARDING THE NEUTRAL ELECTRODE.). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THERE ARE MANY POSSIBILITIES AS TO THE CAUSE OF THE EVENT. IT COULD HAVE BEEN CAUSED BY A DEFECT OF THE NEUTRAL ELECTRODE (I.E., THE GEL), INCORRECT PREPARATION OF THE NEUTRAL ELECTRODE SITE OR APPLICATION OF THE NEUTRAL ELECTRODE, THE ESU'S SETTING(S) BEING TOO HIGH, ACTIVATION TIME(S) BEING TOO LONG AND/OR THE TIMES BETWEEN APPLICATIONS BEING TOO SHORT WHICH CAUSED EXCESSIVE HEATING UNDER THE NEUTRAL ELECTRODE, THE NEUTRAL ELECTRODE BECAME PARTIALLY DETACHED FROM THE PATIENT DURING USE, ETC. (NOTE: THE ESU WAS DISPLAYING WARNING MESSAGES INVOLVING THE NEUTRAL ELECTRODE DURING THE SURGERY.). BASED UPON THE LIMITED INFORMATION PROVIDED, THE LESION WAS MOSTLY A THERMAL BURN (ALTHOUGH AN ALLERGY REACTION CANNOT BE RULED). HOWEVER, THE SIZE OF THE SKIN LESION COMBINED WITH THIS SEVERITY OF THE BURN IS VERY UNUSUAL FOR BEING A THERMALLY INDUCED NECROSIS. NEVERTHELESS, THERE ARE MANY WARNINGS IN THE UNIT'S USER MANUAL ADDRESSING NEUTRAL ELECTRODE BURNS. FINALLY, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE EXACT CAUSE(S) OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A HIP IMPLANTATION PROCEDURE ON THE PATIENT'S LEFT SIDE. THE ESU WAS USED WITH VALLEYLAB HANDLE [PART NUMBER (P/N) INFORMATION NOT PROVIDED (NI), LOT NUMBER (L/N) NI]) AND A DUAL SURFACE NEUTRAL ELECTRODE FROM SKINTACT (P/N RSW 213/5, L/N 230821-0808). THE NEUTRAL ELECTRODE WAS ATTACHED TO THE PATIENT'S RIGHT THIGH. NO INFORMATION WAS PROVIDED REGARDING THE UNIT'S SETTINGS. UPON THE PROCEDURE, A SKIN LESION (BURN/NECROSIS) WAS FOUND UNDER THE NEUTRAL ELECTRODE IN A HORSESHOE-SHAPE OF APPROXIMATE 200 CM² IN SIZE. INITIALLY, THE LESION WAS CONSIDERED AS A 1ST DEGREE BURN, BUT OVER THE COURSE OF A WEEK IT DEVELOPED INTO A 2ND DEGREE BURN. DUE TO THE NECROSIS, A SKIN TRANSPLANT IS BEING PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908338 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other