BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 23789627 · Received December 12, 2025

    Report

    Report Number
    9610614-2025-00086
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 A REACTION TO THE DISINFECTANT OR AN IGNITION/DEFLAGRATION OF THE DISINFECTANT. THE ESU USER MANUAL PROVIDES WARNING INVOLVING DISINFECTION. 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 VIO 3 ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING AN ANAL FISTULA PROCEDURE. THE ESU WAS USED WITH AN ERBE NEUTRAL ELECTRODE [NE, PART NUMBER (P/N): 20193-082, LOT NUMBER (L/N): INFORMATION NOT PROVIDED (NI)]. NO INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY USED IN THE INTERVENTIONAL WORK. THE NE WAS PLACED ON THE PATIENT'S THIGH. PER THE PROVIDED DESCRIPTION OF THE EVENT, A "STAMP-SIZED SKIN LESION" OCCURRED AT THE SURGICAL SITE "IMMEDIATELY AFTER SPRAYING DISINFECTANT." THERE WAS NO INFORMATION CONVEYED TO ERBE IF THE LESION REQUIRED ANY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760774 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Other