BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 18455398 · Received January 5, 2024

    Report

    Report Number
    9610614-2024-00002
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    November 14, 2023
    Report Date
    January 5, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED (NOTE: ACCORDING TO THE SERVICE TECHNICIAN FROM ERBE POLAND, THE INVOLVED BIPOLAR FORCEPS HERE WERE NO INSULATION DEFECTS WITH.). 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. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE UNIT. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PER A REVIEW OF THE ESU'S CHRONOLOGICAL DATA, NO EQUIPMENT ISSUES (E.G., MALFUNCTIONS, ETC.) OCCURRED DURING THE PROCEDURE. AS REPORTED, THE BURN APPEARS TO HAVE BEEN CAUSED BY USER ERROR DUE TO THE INSTRUMENT BEING PLACED ON THE PATIENT AND ACTIVATED ACCIDENTALLY. THERE ARE SEVERAL WARNINGS IN THE UNIT'S USER MANUAL AND NOTES ON USE OF THE BIPOLAR FORCEPS RELATED TO THIS TYPE OF 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 · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING AN ADENOTONSILLECTOMY. THE ESU WAS USED WITH ERBE BIPOLAR FORCEPS [PART NUMBER (P/N): 20195-014, LOT NUMBER (L/N): 213254) AND A ERBE BIPOLAR CABLE (P/N: 20196-055, L/N: INFORMATION NOT PROVIDED). NO INFORMATION WAS PROVIDED IN REGARDS TO THE SETTINGS USED IN THE PROCEDURE. PER THE USER, THE BIPOLAR FORCEPS WERE PLACED ON THE PATIENT AND UNINTENTIONALLY ACTIVATED. AS A RESULT, A BURN/NECROSIS OCCURRED ON THE PATIENT'S NECK. THE BURN WAS 0.5 CM² IN SIZE AND CONTAINED TWO (2) BLISTERS. TO ADDRESS THE NECROSIS, AN UNSPECIFIED WOUND TREATMENT WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908053 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Required Intervention