BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 22748811 · Received August 8, 2025

    Report

    Report Number
    9610614-2025-00049
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 10, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERBE ESU AND NEUTRAL ELECTRODE WERE THOROUGHLY INSPECTED AND TESTED AS APPLICABLE. THE EVALUATIONS WERE AS FOLLOWS: ESU - 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. A REVIEW OF THE ESU'S CHRONOLOGICAL LOG REVEALED THAT THE UNIT'S SETTINGS AT THE TIME OF THE PROCEDURE WERE AUTOCUT, EFFECT 6, 180 WATTS AND SWIFTCOAG, EFFECT 6, 180 WATTS. THE LOG ALSO SHOWED THAT THERE WAS A MESSAGE INDICATING THAT AN ACTIVATION TIME WAS EXCEEDED. IN ADDITION, THERE WAS A NON-ACTIVATION-INTERRUPTING MESSAGE (I.E., B B0). FINALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED ERBE ESU. NEUTRAL ELECTRODE (NE) THE NE WAS INSPECTED. NO EVIDENCE WAS FOUND THAT INDICATED A MATERIAL AND/OR MANUFACTURING DEFECT. A PHOTOGRAPH OF THE NEUTRAL ELECTRODE SHOWED A LARGE, CHARRED AREA AT THE EDGE OF THE PATIENT PAD NEAR ITS CONNECTOR AS WELL AS A SMALL, CHARRED AREA JUST ABOVE. FINALLY, NO ANOMALIES WERE FOUND IN THE DHR OF THE INVOLVED ERBE NEUTRAL ELECTRODE. IN CONCLUSION, NO ERBE EQUIPMENT OR ACCESSORY PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THERE WERE MANY FACTORS INVOLVED IN THE PATIENT INCIDENT (I.E., BURN/NECROSIS AT NE SITE). THE SETTINGS WERE RELATIVELY HIGH AND IN ONE ACTIVATION THE "ON" TIME WAS EXCEEDED. ADDITIONALLY, THE NON-ACTIVATION-INTERRUPTING MESSAGE (I.E., B B0) INDICATED POOR CONTACT BETWEEN THE NE AND THE SKIN (I.E., THERE WAS A PARTIAL, INTRAOPERATIVE DETACHMENT OF THE NEUTRAL ELECTRODE.). IT ALSO, APPEARS THAT THE INVOLVED MEDICAL PERSONNEL DIDN'T RESPOND ADEQUATELY TO THE WARNINGS FROM THE GENERATOR. AS A RESULT, THE CURRENT/HEAT WAS NOT SUFFICIENTLY OR EVENLY DISPERSED BY THE RETURN ELECTRODE WHICH RESULTED IN THE THERMALLY INDUCED BURN/NECROSIS. THERE ARE WARNINGS IN THE ESU'S USER MANUAL AS WELL AS IN THE NEUTRAL ELECTRODE'S NOTES ON USE THAT ADDRESS THE RISK OF PAD BURNS WITH MITIGATION MEASURES PROVIDED TO MINIMIZE BURNS/NECROSIS. 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 AMPUTATION OF THE PATIENT'S LEFT LEG AT THIGH LEVEL. THE ESU WAS USED WITH AN ERBE NESSY OMEGA NEUTRAL ELECTRODE (NE, P/N 20193-082, L/N 250204-0813) [NOTE: THE NE IS ALSO REFERRED TO AS A RETURN ELECTRODE, PATIENT PAD, DISPERSIVE ELECTRODE, PATIENT PLATE, ETC.]. NO INFORMATION WAS PROVIDED REGARDING THE NEUTRAL ELECTRODE CABLE USED OR ANY OTHER ACCESSORY EMPLOYED DURING THE PROCEDURE. THE NE WAS PLACED ON THE PATIENT'S RIGHT THIGH. AT THE CONCLUSION OF THE PROCEDURE, A BURN NECROSIS WAS DISCOVERED UNDER/AROUND THE LOCATION OF THE RETURN ELECTRODE. THE LESION WAS 3 CM2 IN SIZE WITH CHARRING EXTENDING INTO THE SUBCUTANEOUS FATTY TISSUE. 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
    2162534 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other