BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 15779114 · Received November 11, 2022

    Report

    Report Number
    9610614-2022-00041
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    October 17, 2022
    Report Date
    November 11, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ESU WAS INSPECTED/TESTED (NOTE: THE ACTUAL RETURN ELECTRODE USED WAS NOT AVAILABLE FOR AN EVALUATION.). 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 FUNCTIONING PROPERLY (NOTE: SOME UNRELATED SERVE WORK WAS PERFORMED ON THE ESU.). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE REPORTED INFORMATION AND A REVIEW OF THE UNIT'S CHRONOLOGICAL DATA IT APPEARS THAT THERE WERE SIGNIFICANT USER FACTORS INVOLVED WITH THE EVENT. SPECIFICALLY, THERE WERE A LARGE NUMBER OF SYMMETRY AND CURRENT DENSITY WARNINGS IN THE DATA. MOST LIKELY THIS WAS DUE TO LONG ACTIVATIONS WITH INSUFFICIENT COOLING BETWEEN ACTIVATIONS. THESE FACTORS MOST LIKELY LED TO EXCESSIVE HEATING UNDER THE RETURN ELECTRODE WHICH CAUSED THE BURN/NECROSIS. THE USER MANUAL ALSO WARNS USERS OF SUCH POSSIBILITIES. 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 TRANSURETHRAL INCISION OF THE PROSTATE. THE ESU WAS USED WITH A 3M SPLIT RETURN ELECTRODE, PART NUMBER: 9160F, LOT NUMBER: 202504EU WHICH WAS ATTACHED TO THE PATIENT'S LEFT THIGH. NO INFORMATION WAS PROVIDED IN REGARDS TO THE UNIT'S SETTINGS. AFTER THE PROCEDURE, A BURN/NECROSIS WAS DISCOVERED UNDER THE RETURN ELECTRODE. SPECIFICALLY, THERE WAS A 10 CM2 2ND DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2914763 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other