BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 20733402 · Received November 20, 2024

    Report

    Report Number
    9610614-2024-00062
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. 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 CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT (NOTE: PER THE CHRONOLOGICAL DATA IN THE ESU, THE SETTINGS USED WERE BIPOLAR CUT EFFECT 4 AND BIPOLAR SOFT EFFECT 6.). BASED UPON THE PROVIDED INFORMATION, THERE ARE MANY POSSIBLE CAUSES FOR THE REPORTED EVENT. IT IS POSSIBLE THAT THE SETTINGS ON THE DEVICE WERE SET TOO HIGH BY THE USER AND THUS THE INSTRUMENT'S DIELECTRIC STRENGTH WAS EXCEEDED. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE EXACT CAUSE OF THE REPORTED ISSUE (NOTE: THE INVOLVED RESECTOSCOPE SHOULD BE EXAMINED BY STORZ TO ENSURE THAT IT FUNCTIONED PROPERLY.). NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A HYSTEROSCOPIC ENDOMETRIAL RESECTION. THE ESU WAS USED WITH A STORZ RESECTOSCOPE (PART NUMBER: 27040E, LOT NUMBER: 0001) AND A RESECTION LOOP. NO INFORMATION WAS PROVIDED REGARDING ANY OF THE OTHER ACCESSORIES USED IN THE PROCEDURE. ALSO, THE ESU SETTINGS USED WERE NOT PROVIDED. DURING ACTIVATION, A CROWN-SHAPED SPARK FORMED ON THE RESECTION LOOP. THIS RESULTED IN A PERFORATION OF THE UTERUS. AN OPEN HYSTERECTOMY WAS PERFORMED WITH OVER-SEWING OF A SLIGHT SEROSAL DEFECT IN THE BOWEL. THEN, THE PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313389 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization| R