BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 24256832 · Received February 4, 2026

    Report

    Report Number
    9610614-2026-00020
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 4, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K240932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. FURTHERMORE, THE BURN LOCATION WAS NOT AT THE CONTACT POINT OF THE ERBE NESSY OMEGA NEUTRAL ELECTRODE. 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 BURN WAS MOST LIKELY THE RESULT FROM THE SPARK GENERATED BY ALCOHOLIC DISINFECTANT VAPORS WHEN THE ESU WAS ACTIVATED. THE ESU USER MANUAL PROVIDES WARNINGS REGARDING DISINFECTANT IGNITIONS. IN ADDITION, THE SOFTASEPT N ALCOHOLIC DISINFECTANT DATA SHEET WARNS ABOUT ITS HIGH FLAMMABILITY. 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 A CRYPTORCHIDISM. THE ESU WAS USED WITH AN ERBE NESSY OMEGA NEUTRAL ELECTRODE [NE, PART NUMBER (P/N): 20193-082, LOT NUMBER (L/N): 250829-0816], A BOWA HANDLE (P/N: 215-045, NO. 502/.07065), AND AN ALCOHOLIC DISINFECTANT SOFTASEPT N. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY USED IN THE PROCEDURE OR THE GENERATOR SETTINGS. THE NE WAS PLACED ON THE PATIENT'S LEFT THIGH. PER THE PROVIDED DESCRIPTION OF THE EVENT, "SPARKS WERE GENERATED WHEN A TESTICLE WAS MOVED INTO THE SCROTUM" WHICH RESULTED IN A 1 CM2 BURN ABOVE THE RIGHT INGUINAL LIGAMENT. THE BURN WAS TREATED WITH A BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318672 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Other