BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 6833581 · Received August 31, 2017

    Report

    Report Number
    9610614-2017-00020
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    August 31, 2017
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. 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 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. BASED UPON THE REPORTED INFORMATION, IT APPEARS THAT THE BURNS MAY BE RELATED TO CAPACITIVE COUPLING. ELECTRICAL CURRENT AND HEATING FROM ACTIVE INSTRUMENTS TO INACTIVE ACCESSORIES BEING USED IS ALWAYS A POSSIBILITY (NOTE: CURRENT WILL FLOW THE PATH OF LEAST RESISTANCE.). ADDITIONALLY, THIS SITUATION IS INTENSIFIED BECAUSE OF THE SMALL SURGICAL/SURFACE AREA IN WHICH THE PROCEDURE IS BEING PERFORMED. THERE IS A WARNING IN THE GENERATOR'S USER MANUAL ADDRESSING THIS SITUATION. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAVE BEEN SEVERAL PATIENT INCIDENTS DURING CERVICAL CONISATIONS THE ELECTROSURGICAL UNIT (ESU/GENERATOR). THE SETTINGS OF THE ESU WERE CUT, EFFECT 6,180 WATTS. FOR EACH PROCEDURE, THE ESU WAS USED WITH A SPECULUM, BALL FORCEPS, LOOP ELECTRODES, AND CONISATION LOOPS. THE PATIENTS HAD A 1ST DEGREE BURN/NECROSIS ON THE LEFT SIZE OF THE LABIA MAJORA OF APPROXIMATELY 1 TO 2 CM DIAMETER IN SIZE. THE BURNS WERE TREATED WITH OINTMENT AND MONITORED. THE PATIENTS DID NOT REQUIRE ADDITIONAL HOSPITALIZATION OR SURGICAL INTERVENTION. THE ESU WAS DISTRIBUTED BY OUR PARENT COMPANY ((B)(4)) TO A HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613306 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other