BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO DV

    MDR report key: 20472559 · Received October 17, 2024

    Report

    Report Number
    9610614-2024-00056
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K150364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ESU WAS RETURNED AND INSPECTED/TESTED (NOTE: THE NEUTRAL ELECTRODE WAS NOT MADE AVAILABLE TO ERBE FOR AN EXAMINATION.). THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED (NOTE: AN INTERNAL INSPECTION OF GENERATOR REVEALED THAT ALL OF ITS BOARDS AND COMPONENTS WERE INTACT.). THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. THE ESU WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT (NOTE: AS REQUESTED BY INTUITIVE, SOME UNRELATED SERVICE WORK WAS PERFORMED ON THE UNIT AFTER THE EVALUATION.). THE REPORTED ERROR CODE (M-19) WAS FOUND IN THE UNIT'S ERROR LOG. THIS CODE TYPICALLY OCCURS IF THE ESU IS POWERED "OFF", AND THEN "ON" AGAIN ABRUPTLY. THE ERRORING IT IS UNRELATED TO THE SKIN CHANGE WITH BLISTERING THAT WAS FOUND UNDER THE NEUTRAL ELECTRODE. BASED UPON THE LIMITED INFORMATION PROVIDED AND THE CIRCUMSTANCES OF THE REPORTED EVENT, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE EXACT CAUSE(S) OF THE INCIDENT (I.E., THE SKIN CHANGE COULD HAVE BEEN THE RESULT OF A THERMAL BURN, ALLERGIC REACTION, ETC.). 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 PROSTATECTOMY. NO INFORMATION WAS PROVIDED IN REGARDS TO THE ACCESSORIES USED WITH ESU NOR THE SETTINGS EMPLOYED DURING THE PROCEDURE. DURING THE OPERATION, THE ESU WENT BLANK AND THEN CAME BACK "ON" OR WAS TURNED BACK "ON". THE GENERATOR DISPLAYED/REGISTERED ERROR CODE M-19. NEVERTHELESS, THE UNIT FUNCTIONED WITHOUT ANY PROBLEMS AND THE PROSTATECTOMY WAS COMPLETED (NOTE: ALL PORTS WERE RECOGNIZED, AND THE ESU CAUTERIZED PROPERLY.). HOWEVER, A SKIN CHANGE WITH BLISTERING WAS FOUND UNDER THE NEUTRAL ELECTRODE. NO FURTHER DETAILS WERE PROVIDED REGARDING THE PATIENT'S CONDITION OR IF ANY FURTHER TREATMENT WAS PROVIDED TO ADDRESS THE SKIN CHANGE AND BLISTERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035000 ERBE VIO DV ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO DV

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other