BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 24607171 · Received March 16, 2026

    Report

    Report Number
    9610614-2026-00052
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 20, 2026
    Report Date
    March 16, 2026
    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 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. ADDITIONALLY, 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. IF RETURNED, THE TELESCOPIC SMOKE EVACUATION HANDLE WILL BE SENT TO THE MANUFACTURER FOR THEIR EVALUATION. HOWEVER, BASED UPON THE PROVIDED INFORMATION; IT IS POSSIBLE THAT THE HANDLE, WHICH WAS STILL HOT, CAME INTO CONTACT WITH THE PATIENT OR WAS PLACED ON HER DURING THE PROCEDURE. NEVERTHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERBE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT DURING A BEAST REDUCTION SURGERY. THE ESU WAS USED WITH A TELESCOPIC SMOKE EVACUATION HANDLE (PART NUMBER 20321-060, LOT NUMBER 2503178) MANUFACTURED BY ZHEJIANG MEDSTAR TECHNOLOGY CO., LTD. NO INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY USED IN THE PROCEDURE OR THE SETTINGS OF THE EQUIPMENT EMPLOYED. DURING THE PROCEDURE A THERMAL BURN OCCURRED BELOW THE SURGICAL SITE. THE LESION WAS A 3 CM² IN SIZE AND APPEARANCE OF REDNESS WITH BLISTERING. TO ADDRESS THE ISSUE, THE NECROSIS WAS EXCISED DURING THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670863 ERBE VIO 3 ERBE ELECTROSURGICAL UNIT VIO 3 GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention