BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 20492933 · Received October 21, 2024

    Report

    Report Number
    9610614-2024-00058
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 21, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU AND BALL ELECTRODE WERE THOROUGHLY INSPECTED/TESTED. 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 (NOTE: NO DEFECTS WERE FOUND WITH THE BALL ELECTRODE. IT WAS WITHIN SPECIFICATIONS.). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE DESCRIPTION OF THE EVENT, MOST LIKELY ONCE DIATHERMY WAS APPLIED, COMBUSTION OCCURRED DUE TO THE PRESENCE OF THE FLAMMABLE DISINFECTANTS AND/OR THEIR VAPORS THAT WERE AROUND AN/OR ON THE SWAB AND DRESSING. THE MINOR INJURIES TO THE PATIENT'S FINGERS COULD POSSIBLY HAVE BEEN CAUSED BY EXTINGUISHING THE FLAMES. THERE ARE WARNINGS IN THE ERBE ESU USER MANUAL ADDRESSING THESE ISSUES (I.E., NOT TO USE FLAMMABLE DISINFECTANTS OR IF USING A FLAMMABLE DISINFECTANT, IT MUST BE DRY/COMPLETELY EVAPORATED PRIOR TO ACTIVATION.). ADDITIONALLY, THE PRODUCT DATA SHEETS FOR THE SKINSEPT AND OCTENISEPT DISINFECTANTS USED WARNS THAT THE DISINFECTANTS ARE HIGHLY FLAMMABLE, AND THE VAPORS CAN FORM EXPLOSIVE MIXTURES WITH AIR. 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 CONIZATION (CONE BIOPSY) AND LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP). THE ESU WAS USED WITH AN ERBE BALL ELECTRODE (PART NUMBER: 21191-024, LOT NUMBER: WO240431). NO INFORMATION WAS PROVIDED REGARDING THE EQUIPMENT'S SETTINGS. UPON ACTIVATING THE ESU, FLAMES FORMED ON THE INSERTED SWAB AT THE SURGICAL SITE WHERE THE DISINFECTANTS SKINSEPT AND OCTENISEPT WERE USED AND ON THE SURGICAL COVER. AFTER EXTINGUISHING THE FLAMES, A SLIGHT BURN OF THE EXTERNAL GENITALIA INCLUDING THE URETHRAL ORIFICE OF 1-2 CM IN SIZE WAS FOUND. THE PATIENT ALSO COMPLAINED OF NUMBNESS AND WHITISH DISCOLORATION OF THE FINGERS OF HER RIGHT HAND. THERE WERE SMALL SPOTS OF WHITISH DISCOLORATION OF THE FINGERTIPS UP TO 5 MM IN SIZE BUT NO BLISTERS. THE PATIENT'S WOUND WAS TREATED. SHE WAS HOSPITALIZED AND MONITORED FOR 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010697 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Hospitalization| O