BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 16333820 · Received February 9, 2023

    Report

    Report Number
    9610614-2023-00010
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    January 23, 2023
    Report Date
    February 9, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ESU WAS 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 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. TO FURTHER INVESTIGATE THE EVENT, THE CHRONOLOGICAL DATA AT THE TIME OF THE SURGERY WAS ANALYZED. THE DATA REVEALED EXCESSIVELY LONG ACTION TIMES (45 SECONDS) WITH VERY SHORT PAUSES (10 SECONDS). AS A RESULT, AN EXTREME AMOUNT OF HEAT BUILT UP AND MELTED THE INSULATION OF THE INSTRUMENT. PER THE USER MANUAL, EQUIPMENT AND/OR PATIENT TISSUE ISSUES MAY ARISE IF ACTIVATION ARE TOO LONG AND IF THE RELATIVE ACTION TIME EXCEEDS 25%. 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 CONIZATION. THE ESU WAS USED WITH AN ERBE BALL ELECTRODE (PART NUMBER 21195-328, LOT NUMBER WO349989). AN ERBE NESSY OMEGA NEUTRAL ELECTRODE WAS ATTACHED TO THE PATIENT'S RIGHT THIGH. THE ESU SETTINGS WERE HIGH CUT MODE, EFFECT 3 AND SPRAY COAG MODE, EFFECT 4. DURING THE PROCEDURE, THE PLASTIC INSULATION ON THE DISTAL END OF THE BALL ELECTRODE MELTED AND BECAME EMBEDDED IN THE TISSUE OF THE PORTIO. THEREFORE, INTRAOPERATIVELY, THE PLASTIC WAS REMOVED FROM THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358512 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention