BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 14697576 · Received June 15, 2022

    Report

    Report Number
    9610614-2022-00019
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 15, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY 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 WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE (NOTE: A PHOTOGRAPH OF THE RETURN ELECTRODE SHOWED SEVERAL BLACK SPOTS AT THE LEVEL OF THE TAB.). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THE FACT THAT THE RETURN ELECTRODE WAS ATTACHED TO THE INFANT'S FOOT CERTAINLY PREVENTED IT FROM MAKING A FULL-SURFACE CONTACT WITH THE SKIN. AT THE POINTS OF CONTACT WITH THE TOES, THE HIGH CURRENT DENSITY MOST LIKELY LED TO EXCESSIVE HEATING AND THUS TO THE BURN/NECROSIS. THIS IS A CLEAR CASE OF USER ERROR. IN THE INSTRUCTIONS FOR USE OF THE RETURN ELECTRODE, THE RETURN ELECTRODE IS TO BE PLACED ON AN APPROPRIATE VASCULARIZED AREA OF MUSCLE MASS AND NOT ON BONY PARTS OF THE BODY. ALSO, THE ENTIRE SURFACE OF THE RETURN ELECTRODE MUST BE APPLIED TO THE SKIN. 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 THE PATIENT'S TREATMENT FOR NECROTIZING ENTEROCOLITIS. THE ESU WAS USED WITH AN ERBE RETURN ELECTRODE (I.E., AN ERBE SINGLE RETURN ELECTRODE, PART NUMBER 20193-073, LOT NUMBER 211116-0805.). THE SETTINGS OF THE UNIT WERE NOT PROVIDED. THE RETURN ELECTRODE WAS PLACED ON THE INFANT'S FOOT. UPON THE PROCEDURE, A BURN/NECROSIS WAS FOUND UNDER THE RETURN ELECTRODE. THE LESION WAS 1 CM2 ON THE RIGHT FOOT WITH DORSAL CHARRING TO THE BONE ON THE BIG TOE AND TWO ADJACENT TOES. AFTER AN INITIAL CONSERVATIVE THERAPY, DEBRIDEMENT OF THE NECROSIS AND PLASTIC COVERAGE WAS PERFORMED ON (B)(6) 2022. FURTHER TREATMENT IS UNKNOWN. THE ESU WAS DISTRIBUTED TO A HOSPITAL IN THE GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813833 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female Required Intervention