BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE VIO 300 D

    MDR report key: 20124875 · Received September 3, 2024

    Report

    Report Number
    9610614-2024-00049
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED AND THE INVOLVED NEUTRAL ELECTRODE WAS ALSO EVALUATED. THE FINDINGS WERE AS FOLLOWS: ESU THE GENERATOR 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 UNIT WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE ESU. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. NEUTRAL ELECTRODE A PROVIDED PHOTOGRAPH OF THE RETURN ELECTRODE SHOWED THAT THERE WAS A TEAR IN THE CONDUCTIVE SURFACE PROXIMAL TO THE CONNECTION TAB. THE DAMAGE TO THE ACCESSORY WAS CONFIRMED DURING OUR ASSESSMENT OF THE PATIENT PAD. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING DEFECT. IT APPEARS THAT THE NEUTRAL ELECTRODE ENCOUNTERED AN EXCESSIVE AMOUNT OF PULL/TENSILE FORCE CAUSING IT TO TEAR (NOTE: A REVIEW OF OUR COMPLAINT DATA DIDN'T SHOW ANY OTHER INCIDENTS OF THIS TYPE.). THIS DAMAGE LED TO THE CURRENT NOT BEING DISPERSED PROPERLY AND THUS THE SMALL BURN UNDER THE NEUTRAL ELECTRODE. IN CONCLUSION, NO DETERMINATION COULD BE MADE AS TO WHEN THE DAMAGE TO THE RETURN ELECTRODE OCCURRED OR WHAT EXACTLY CAUSED THE DAMAGE TO THE ACCESSORY. THE NEUTRAL ELECTRODE NOTES ON USE (NOU) EXPLICITLY STATES THAT THE PRODUCT MUST BE CHECKED FOR EXTERNAL DAMAGE BEFORE USE (IN PARTICULAR CRACKS, KINKS, BREAKS OR DEFECTS ON THE PRODUCT) AND THAT THE PRODUCT MUST NOT BE USED IF IT IS DAMAGED. ALSO, THE NOU STIPULATES THAT THE PRODUCT MUST BE PROTECTED FROM ANY MECHANICAL DAMAGE. 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 AN ENDOSCOPIC MUCOSAL RESECTION (EMR). THE ESU WAS USED WITH AN ERBE NESSY OMEGA NEUTRAL ELECTRODE (ALSO REFERRED TO AS A RETURN ELECTRODE, PATIENT PAD, ETC.) [PART NUMBER: 20193-082, LOT NUMBER: 240416-0814]. THE NEUTRAL ELECTRODE WAS PLACED ON THE PATIENT'S RIGHT UPPER ARM. NO INFORMATION WAS PROVIDED REGARDING ANY OF THE OTHER ACCESSORIES USED IN THE PROCEDURE. ALSO, THE ESU SETTINGS USED WERE NOT PROVIDED. AFTER THE PROCEDURE, PER A PROVIDED PHOTOGRAPH, THERE WAS A SMALL BURN (I.E., BLISTERING, AND SURROUNDING REDNESS) OF APPROXIMATELY 3 MM X 4 MM ON THE PATIENT'S SKIN UNDER THE NEUTRAL ELECTRODE. NO INFORMATION WAS PROVIDED IN REGARDS TO THE INJURY BEING SERIOUS OR THE NEED FOR MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834097 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other