BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 24390016 · Received February 19, 2026

    Report

    Report Number
    9610614-2026-00033
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 19, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ESU WAS INSPECTED/TESTED. 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. IN ADDITION, THE CHRONOLOGICAL DATA STORED IN THE UNIT WAS EVALUATED. THERE WERE NO ERROR OR WARNING MESSAGES. FINALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE INFORMATION PROVIDED AND OUR EVALUATION, THE LESION WAS MOST LIKELY THE RESULT OF AN IGNITION/DEFLAGRATION OF THE DISINFECTANT OR A REACTION TO THE DISINFECTANT. THE ESU USER MANUAL PROVIDES WARNINGS INVOLVING THE USE OF DISINFECTANTS IN CAUTERY PROCEDURES. FINALLY, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE 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 AN ABSCESS EXCISION OF THE LEFT AXILLA. THE ESU WAS USED WITH AN ERBE NEUTRAL ELECTRODE [NE, PART NUMBER (P/N): 20193-082, LOT NUMBER (L/N): INFORMATION NOT PROVIDED (NI)] AND WAS ATTACHED TO THE RIGHT THIGH. IT WAS NOTED THAT OCTENISEPT WAS USED AS A DISINFECTANT. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY USED IN THE PROCEDURE OR ESU SETTINGS EMPLOYED FOR THE OPERATION. PER THE PROVIDED DESCRIPTION OF THE EVENT, A SECOND-DEGREE BURN OCCURRED IN THE DORSAL AND CAUDAL AXILLA OF THE PATIENT. THE SKIN LESION SIZE WAS "REPORTED TO BE 2% OF THE BODY SURFACE AREA (DORSAL APPROX. 19CM X 7CM AND CAUDAL APPROX. 7CM X 5CM)." THE INCIDENT REQUIRED WOUND THERAPY WITH A FATTY STERILE WOUND DRESSING AND AN EXTENDED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450861 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other| R| H