BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 300 D

    MDR report key: 1264708 · Received December 10, 2008

    Report

    Report Number
    9610614-2008-00022
    Event Type
    Other
    Date Received
    December 10, 2008
    Date of Event
    November 13, 2008
    Report Date
    December 10, 2008
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTROSURGICAL (ESU/GENERATOR) WAS RETURNED AND THROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE ESU. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS (NOTE: UNRELATED TO THE REPORTED ISSUE SOME DIRECTED UPGRADE WORK WAS PERFORMED ON THE GENERATOR). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE USE OF THE OTHER MFR MEGA RETURN ELECTRODE IS NOT RECOMMENDED FOR USE WITH ERBE EQUIPMENT. SPECIFICALLY, THE USE OF THE ELECTRODE CAN EFFECT THE ESU'S ABILITY TO DELIVER THE PROPER OUTPUT TO TARGET TISSUE (I.E. THE USE OF THE MEGA ELECTRODE MAY RESULT IN HIGH IMPEDANCE WHICH CAN REDUCE THE AVAILABLE VOLTAGE NEEDED AT THE TARGET SITE.). THEREFORE, THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS AND THEY WILL BE REMINDED NOT TO USE THE OTHER MFR RETURN ELECTRODES WITH OUR EQUIPMENT. FURTHERMORE, ADDITIONAL IN-SERVICE TRAINING WILL BE OFFERED TO THE ACCOUNT. NO TRENDS WERE IDENTIFIED WITH THE REPORTED INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS USED IN A LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP). THE SETTINGS FOR THE ESU WERE AUTO CUT 150 WATTS, EFFECT 5 AND SPRAY COAG 60 WATTS, EFFECT 1. THE PHYSICIAN ENCOUNTERED INTERMITTENT OUTPUT AND THERE WAS BLEEDING. THEREFORE, MEDICAL PERSONNEL SWITCHED FROM USING THE MODEL GENERATOR AND ANOTTHER MFR MEGA RETURN ELECTRODE TO AN ERBE ICC MODEL ESU AND A 3M PAD. HEMOSTASIS WAS ACHIEVED BUT THE PT LOSS APPROXIMATELY 400 CC OF BLOOD; THEREFORE, A UNIT OF BLOOD WAS ADMINISTERED. THE PT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 300 D ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention