BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 22478557 · Received July 11, 2025

    Report

    Report Number
    9610614-2025-00039
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 11, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERBE ESU AND BICLAMP INSTRUMENT WERE THOROUGHLY EVALUATED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE UNIT. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE ESU. AN EXAMINATION OF THE BICLAMP INSTRUMENT REVEALED SIGNS OF USE, BUT NO DEFECTS. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THE ERBE BICLAMP INSTRUMENT WAS PLACED ON THE COVER OF THE PATIENT'S ABDOMEN BETWEEN TWO ACTIVATIONS. THE BURN WAS MOST LIKELY CAUSED BY THE INSTRUMENT BEING PLACED DOWN ON THE PATIENT WHILE STILL HOT. THE ESU USER MANUAL AND THE BICLAMP NOTES ON USE WARNS USERS NOT TO PLACE INSTRUMENTS ON PATIENTS AND TO STORE INSTRUMENTS NOT BEING USED AWAY FROM THE PATIENT. 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 OPEN ABDOMINAL HYSTERECTOMY. THE ESU WAS USED WITH AN ERBE BICLAMP INSTRUMENT (PART NUMBER 20195-200, LOT NUMBER WO446391) AND A COMEPA NEUTRAL ELECTRODE (NOTE: SPECIFIC INFORMATION REGARDING THE ELECTRODE WAS NOT CONVEYED TO ERBE.). NO INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORIES USED IN THE SURGERY OR THE EQUIPMENT'S SETTINGS. INTRAOPERATIVELY, A BURN ON THE PATIENT'S SKIN OCCURRED BELOW THEIR NAVAL (NOTE: IT WAS REPORTED THE ERBE BICLAMP INSTRUMENT, BETWEEN TWO ACTIVATIONS, WAS PLACED ON THE COVER OF THE PATIENT'S ABDOMEN.). THE BURN/NECROSIS WAS 2.4 CM² IN SIZE; HOWEVER, NO FURTHER TREATMENT WAS DEEMED NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995223 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other