BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ICC 300 E

    MDR report key: 23071721 · Received September 17, 2025

    Report

    Report Number
    9610614-2025-00058
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K953738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED (NOTE: THE ERBE ESU PENCIL WAS NOT MADE AVAILABLE FOR THE EVALUATION.). 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. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE DESCRIPTION OF THE EVENTS, MOST LIKELY ONCE DIATHERMY WAS APPLIED, COMBUSTION OCCURRED DUE TO THE PRESENCE OF A FLAMMABLE DISINFECTANT(S) AND/OR ITS VAPORS THAT WERE AROUND THE INCISION SITE. 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.). 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 CESAREAN SECTION. THE ESU WAS USED WITH AN ERBE SLIM-LINE ELECTROSURGICAL PENCIL WITH 2 BUTTONS [PART NUMBER (P/N) 20190-065, LOT NUMBER L/N) 022125 OR 023054] AND AN ERBE NESSY OMEGA NEUTRAL ELECTRODE (P/N 20193-082, L/N 250521-0817). THE NEUTRAL ELECTRODE WAS ATTACHED TO THE PATIENT'S THIGH. NO INFORMATION WAS PROVIDED REGARDING THE EQUIPMENT'S SETTINGS. UPON ACTIVATING THE GENERATOR, FLAMES FORMED WITH THERE WAS HEAT AT/AROUND THE INCISION SITE. THIS RESULTED IN A 30 CM² AREA OF REDNESS WITH BLISTERING. THE WOUND WAS TREATED SYMPTOMATICALLY DUE TO THE SKIN LESION. THE SAME PROBLEM OCCURRED DURING A SECOND CESAREAN SECTION ON THE SAME DAY WITH THE SAME ESU (NOTE: NO SPECIFIC INFORMATION WAS CONVEYED TO ERBE REGARDING THE SECOND EVENT.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705133 ERBE ICC 300 E ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 300 E

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Other