BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ESU MODEL VIO 300 D

    MDR report key: 17265797 · Received July 6, 2023

    Report

    Report Number
    9610614-2023-00043
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 6, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU AND BALL ELECTRODE WERE THOROUGHLY INSPECTED/TESTED. THE FINDINGS WERE AS FOLLOWS: ESU A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BALL ELECTRODE SPECIFICALLY, THE PLASTIC COATING AT THE DISTAL END HAD A LIGHT DISCOLORATION (NOTE: THE BALL ELECTRODE HAS A DIELECTRIC STRENGTH OF 4,300 VP.). NO ANOMALIES WERE FOUND IN THE REVIEW OF THE BALL ELECTRODE'S DHR. THE ELECTRODE WAS THERMALLY DAMAGED. THE MELTING OF THE INSULATION OF THE BALL ELECTRODE WAS NOT CAUSED BY A DEFECTIVE ESU OR A MANUFACTURING DEFECT OF THE ELECTRODE. THE DAMAGE TO THE DEVICE IS TYPICAL OF THE GENERATOR BEING USED AT A TOO HIGH DUTY CYCLE WITHOUT OBSERVING THE PAUSE TIMES DESCRIBED IN THE ESU'S USER MANUAL. THE SPRAYCOAG MODE WITH A VOLTAGE OF 4,300 VP CAN LEAD TO THIS TYPE OF DAMAGE TO AN ELECTRODE IF THE DUTY CYCLE OF 25% IS EXCEEDED SIGNIFICANTLY. THAT IS, THE DISTAL END OF THE INSTRUMENT CAN HEAT UP SO MUCH THAT THE MELTING POINT OF 155 DEGREES CELSIUS IS EXCEEDED, WHICH CAN LEAD TO THE POLYPROPYLENE OF THE INSULATION MELTING. THIS IS ALSO EXPLICITLY POINTED OUT IN THE NOTES ON USE FOR THE ELECTRODE. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. 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 LAPAROSCOPY TO PERFORM A CERVICAL CONIZATION. THE ESU WAS USED WITH AN ERBE BALL ELECTRODE [PART NUMBER (P/N) 21191-366, LOT NUMBER (L/N) WO385039]. THE ELECTRODE IS NOT DISTRIBUTED IN THE U.S. AN ERBE NESSY OMEGA RETURN ELECTRODE (P/N 20193-082, LOT NUMBER: 230207-0813) WAS ATTACHED TO THE PATIENT'S RIGHT THIGH. THE ESU SETTINGS WERE SPRAYCOAG MODE, EFFECT 2 AND AUTOCUT MODE, EFFECT 2. DURING AN ACTIVATION OF THE ELECTRODE, THE INSULATION MELTED AND DRIPPED ON THE PATIENT'S TISSUE. THE STUCK PARTICLES AS POSSIBLE WERE EXCISED FROM THE PATIENT DURING THE PROCEDURE. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY OR PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885608 ERBE ESU MODEL VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other