BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 200 S

    MDR report key: 22866706 · Received August 21, 2025

    Report

    Report Number
    9610614-2025-00054
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ERBE ESU WAS THOROUGHLY INSPECTED AND TESTED [NOTE: THE NEUTRAL ELECTRODE (NE) WAS NOT MADE AVAILABLE TO ERBE FOR AN EXAMINATION.]. THE GENERATOR WAS FOUND TO BE FUNCTIONING AS INTENDED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. THE UNIT WAS/IS WITHIN SPECIFICATION AND ALL FEATURES WERE/ARE WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED ERBE ESU. BASED UPON THE PROVIDED INFORMATION AND EVALUATION, THE BURN WAS NOT CAUSED BY A DEFECT OF THE ESU OR NESSY OMEGA NEUTRAL ELECTRODE. THE NE WAS USED A SECOND TIME PER THE INCIDENT DESCRIPTION. THEREFORE, THE ADHESIVE STRENGTH WAS NO LONGER SUFFICIENT TO ENSURE FULL SKIN CONTACT ON THE CALF. THIS RESULTED IN A HIGH CURRENT DENSITY AT THE REMAINING CONTACT POINTS OF THE DISPERSIVE ELECTRODE AND THE SUBSEQUENT BURN/NECROSIS. THE ERBE NESSY OMEGA NEUTRAL ELECTRODE'S NOTES ON USE (NOU) INSTRUCTS THAT THE NE IS A SINGLE-USE PRODUCT THAT MUST NOT BE USED MORE THAN ONCE. 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 ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE ESU WAS USED WITH AN ERBE NESSY OMEGA NEUTRAL ELECTRODE [NE, PART NUMBER (P/N) 20193-082, LOT NUMBER (L/N) INFORMATION NOT PROVIDED] (NOTE: THE NE IS ALSO REFERRED TO AS A RETURN ELECTRODE, PATIENT PAD, DISPERSIVE ELECTRODE, PATIENT PLATE, ETC.). NO INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY EMPLOYED DURING THE PROCEDURE. ALSO, THE ESU SETTINGS USED WERE NOT PROVIDED. PER THE REPORTED INCIDENT, THE NE WAS USED FOR A SECOND TIME AND PLACED ON THE PATIENT'S CALF. DURING THE INTERVENTIONAL WORK, THE MEDICAL PERSONNEL OBSERVED THAT THE PATIENT PAD WAS NOT ADHERING TO THE CALF AS WELL AS EXPECTED. AT THE END OF THE PROCEDURE, A BURN WAS OBSERVED UNDER THE LOCATION OF THE NE THAT CORRESPONDED TO THE EQUIPOTENTIAL RING OF THE PAD. THE LESION WAS OBSERVED TO BE 3 CM LONG, DEEP, AND ELONGATED WOUND WITH CHARRED AREAS. NO INFORMATION WAS CONVEYED TO ERBE AS TO HOW THE BURN/NECROSIS WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204217 ERBE VIO 200 S ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 S

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other