BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 16929501 · Received May 15, 2023

    Report

    Report Number
    9610614-2023-00028
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 15, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED UPON THE PROVIDED INFORMATION, MOST LIKELY ONCE DIATHERMY WAS APPLIED, COMBUSTION OCCURRED DUE TO FLAMMABLE VAPORS AND/OR DISINFECTANT THAT WAS AROUND THE OPERATIVE SITE (I.E., ON THE DRAPE, GAUZE, ETC.). THERE ARE WARNINGS IN THE ERBE ESU USER MANUAL ADDRESSING THESE ISSUES (I.E., WHEN USING DISINFECTANTS, CARE MUST BE TAKEN TO ENSURE THAT THEY ARE NOT FLAMMABLE OR THAT THESE AGENTS HAVE EVAPORATED COMPLETELY BEFORE USING THE ELECTROSURGICAL UNIT. IT MUST ALSO BE CHECKED THAT NO DISINFECTANT HAS ACCUMULATED UNDER THE PATIENT, IN BODY RECESSES SUCH AS THE NAVAL, OR IN BODY CAVITIES, SUCH AS THE VAGINA.). IN ADDITION, THE INSTRUCTIONS FOR USE OF THE DISINFECTANT USED (KODAN) INDICATES THAT IT IS FLAMMABLE AND CAN BE EASILY IGNITED BY SPARKS, OPEN FLAMES AND OTHER IGNITION SOURCES ABOVE 24O CELSIUS AND THAT THE ALCOHOLIC DISINFECTANT ON THE SKIN MUST BE DRY BEFORE USING ELECTRICAL DEVICES. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. 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 AN INTRAOPERATIVE DILATATION OF THE COMMON FEMORAL ARTERY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ON A LEG. TH ESU WAS USED WITH AN ERBE MONOPOLAR ELECTRODE HANDLE [PART NUMBER (P/N) 20190-045, LOT NUMBER (L/N) INFORMATION NOT PROVIDED (NI)]. AN ERBE NESSY OMEGA RETURN ELECTRODE (P/N 20193-082, LOT NUMBER: 220822-0812) WAS ATTACHED TO THE PATIENT'S RIGHT THIGH. THE ESU SETTINGS WERE SPRAYCOAG, EFFECT 2, 45 WATTS; AUTOCUT, EFFECT 4, 70 WATTS; AND SWIFTCOAG, EFFECT 3, 65 WATTS. UPON ACTIVATION (I.E., DURING THE COAGULATION OF THE SUBCUTANEOUS TISSUE AT THE BEGINNING OF THE PROCEDURE), A COMBUSTION/FIRE OCCURRED ON THE SURGICAL DRAPE AND PATIENT. THE EXACT AREA IN WHICH THE FLAME FORMED AND THE LOCATION OF THE BURN ON THE PATIENT WAS NOT REPORTED TO ERBE. THE NECROSIS (PRESUMABLY ON THE PATIENT'S LEG) WAS A 1ST DEGREE BURN (REDNESS, NO BLISTERING) OF 1.5 CM X 1.7 CM. TO ADDRESS THE ISSUE, AN ARGONSULFAN OINTMENT WAS APPLIED TO THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663312 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other