BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 16240134 · Received January 25, 2023

    Report

    Report Number
    9610614-2023-00004
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 25, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 SEVERAL SYMMETRY AND CURRENT DENSITY WARNINGS IN THE DATA. THE LONG SIDE OF THE RETURN ELECTRODE SHOULD HAVE FACED THE SURGICAL SITE. ALSO, THE EFFECT AND/OR ACTIVATION TIME SHOULD HAVE BEEN REDUCED TO ENSURE SUFFICIENT COOLING UNDER THE RETURN ELECTRODE. MOST LIKELY EXCESSIVE HEATING OCCURRED UNDER THE RETURN ELECTRODE CAUSING THE BURN/NECROSIS. THE USER MANUAL OF THE ESU AND THE NOTES ON USE OF THE RETURN ELECTRODE 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 SPINAL OPERATION (RE-DISTRACTION OF SPINE). THE ESU WAS USED WITH AN ERBE NESSY SPLIT RETURN ELECTRODE, 78 CM2 (PART NUMBER 20193-071, LOT NUMBER 211119-0806). THE RETURN ELECTRODE WAS ATTACHED TO THE PATIENT'S LEFT THIGH WITH THE SHORT SIDE FACING THE SURGICAL FIELD. NO INFORMATION WAS PROVIDED IN REGARDS TO THE UNIT'S SETTINGS. DURING ACTIVATIONS, THE UNIT DISPLAYED "NESSY CURRENT DENSITY WARNING" AND ACTIVATION WAS BRIEFLY PAUSED. AFTER THE PROCEDURE AND WHEN REMOVING THE RETURN ELECTRODE THERE WAS A SKIN DETACHMENT WITHOUT REDDENING OF THE SIZE OF 23 MM IN DIAMETER UNDER THE PAD. THE SKIN LESION WAS TREATED WITH A HYDROCOLLOID BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793380 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Required Intervention