BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ICC 200 E

    MDR report key: 12406465 · Received September 1, 2021

    Report

    Report Number
    9610614-2021-00016
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 1, 2021
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERBE ESU AND ACCESSORIES WERE 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 WORKING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). THE BALL ELECTRODE (BEING MORE THAN 21 YEARS OLD) WAS MECHANICALLY DAMAGED/BENT WITH ITS PLASTIC INSULATION HAVING SEVERE NOTCHES/DAMAGE. THE BALL ELECTRODE SHOULD NOT HAVE BEEN IN USE. THE MONOPOLAR CABLE WAS NOT DAMAGED. THE REST OF THE ACCESSORIES WERE FROM OTHER MEDICAL COMPANIES. BASED UPON THE DESCRIPTION OF THE EVENT, ONCE DIATHERMY WAS APPLIED, COMBUSTION OCCURRED DUE TO THE PRESENCE OF THE VAPORS AND/OR LIQUID DISINFECTANT. THERE ARE WARNINGS IN THE ERBE ESU USER MANUAL ADDRESSING THESE ISSUES (I.E., NOT TO USE FLAMMABLE DISINFECTANTS OR IF USING A FLAMMABLE DISINFECTANT, IT MUST BE DRY/COMPLETELY EVAPORATED PRIOR TO ACTIVATION.). ADDITIONALLY, THE SAFETY INSTRUCTIONS FOR THE BRAUNODERM DISINFECTANT USED STATES THAT IT IS HIGHLY FLAMMABLE (RISK OF FIRE /BURNS) AND IT MUST DRY ON THE SKIN 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 THE REMOVAL OF CONDYLOMA IN THE PELVIC AREA. THE ESU WAS USED WITH AN ERBE RETURN ELECTRODE AND MONOPOLAR CABLE (NOTE: INFORMATION REGARDING THE PART NUMBERS AND LOT NUMBERS WERE NOT PROVIDED.) AS WELL AS A 4 MM (STRAIGHT SHAFT) BALL ELECTRODE (PART NUMBER 20191-222, LOT NUMBER AS). THE RETURN ELECTRODE WAS PLACED ON THE PATIENT'S THIGH. THE SETTINGS OF THE ESU WERE NOT CONVEYED TO ERBE. ACCORDING TO OUR CHECKLIST, THE SURGEON ACTIVATED THE BALL ELECTRODE WITHOUT APPROVAL FOR THE OPERATION AND WITHOUT THE DISINFECTANT (BRAUNODERM) HAVING BEEN COMPLETELY DRY/EVAPORATED (NOTE: THE PATIENT WAS LYING ON WET CLOTHS SOAKED WITH THE DISINFECTANT IN A LITHOTOMY POSITION.). A SPARK OCCURRED WHICH IGNITED THE DISINFECTANT. THIS RESULTED IN THE PATIENT'S BUTTOCKS, UROGENITAL AREA, AND BACK HAVING BLISTERS AS WELL AS A BROWN DISCOLORATION. THEREFORE, A WOUND DRESSING WITH PANTHENOL AND FREKACID WAS APPLIER TO MANAGE THE BURN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308517 ERBE ICC 200 E ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 200 E

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention