BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 23741181 · Received December 8, 2025

    Report

    Report Number
    9610614-2025-00081
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THE CHRONOLOGICAL DATA STORED IN THE UNIT WAS EVALUATED. THERE WERE NO ERROR OR WARNING MESSAGES. ALSO, THE SETTINGS USED, ACTIVATIONS, ETC. WERE TYPICAL. AS A RESULT, A SPECIFIC CAUSE(S) OF THE EVENT CANNOT BE DETERMINED. THAT IS, THERE ARE MANY SPECULATIVE POSSIBLE SCENARIOS THAT COULD HAVE CAUSED THE BURN. 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 S A TESTICULAR ECTOPY PROCEDURE. THE ESU WAS USED WITH A MONOPOLAR ELECTRODE [MANUFACTURER: INFORMATION NOT PROVIDED (NI), PART NUMBER (P/N): SE100, LOT NUMBER (L/N): 2501033] AND A NEUTRAL ELECTRODE (MANUFACTURER: 3M, P/N: 9160F, L/N: 02802CG). NO INFORMATION WAS PROVIDED IN REGARD TO ANY OTHER ACCESSORY USED IN THE OPERATION OR THE EQUIPMENT SETTINGS. THE NEUTRAL ELECTRODE WAS PLACED ON THE PATIENT'S RIGHT THIGH. DURING THE PROCEDURE, A BURN OCCURRED ON THE INFANT'S LEFT GROIN. IT WAS A 3RD DEGREE BURN (WHITISH PLAQUES) AND WAS 0.3 CM² IN SIZE. BIAFINE WAS USED TO TREAT THE SKIN LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130328 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Male Other