BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 S

    MDR report key: 15986155 · Received December 15, 2022

    Report

    Report Number
    9610614-2022-00047
    Event Type
    Injury
    Date Received
    December 15, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY 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 WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE (NOTE: A PHOTOGRAPH OF THE RETURN ELECTRODE WITH ITS CABLE SHOWED A 3 X 1 CM BROWNISH DISCOLORATION ON THE EDGE OF THE PAD, BUT THERE WAS NO EVIDENCE OF THE PAD BEING DEFECTIVE.). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED WITH THE REPORTED EVENT. THE APPLICATION OF THE RETURN ELECTRODE MAY NOT HAVE BEEN SUITABLE, THE ACTIVATION OF THE ESU WAS TOO LONG TO ALLOW THE CURRENT/HEAT TO DISSIPATE, ETC. WARNINGS IN THE ESU'S USER MANUAL AND THE NOTES ON USE OF RETURN ELECTRODE THAT CONVEY TO THE END USER RISK AND MITIGATION MEASURES TO MINIMIZE THE POSSIBILITY OF PAD BURNS. 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 A SURGICAL PROCEDURE. THE ESU WAS USED WITH AN ERBE NESSY OMEGA RETURN ELECTRODE (PAD, PART NUMBER 20193-082, LOT NUMBER UNKNOWN). THE SETTINGS OF THE UNIT WERE NOT PROVIDED. AFTER THE SURGERY, A BURN WAS DISCOVERED ON THE EDGES UNDER THE PAD THAT WAS PLACED ON THE PATIENT'S THIGH. THE EXTENT AND SEVERITY OF THE NECROSIS WAS NOT CONVEYED TO ERBE. ADDITIONALLY, NO DETAILS WERE PROVIDED IN REGARDS TO HOW THE BURN WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258749 ERBE VIO 300 S ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 S

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Other