BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 200D

    MDR report key: 963963 · Received December 12, 2007

    Report

    Report Number
    9610614-2007-00027
    Event Type
    Other
    Date Received
    December 12, 2007
    Report Date
    December 12, 2007
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED BY PERFORMING A TECHNICAL SAFETY CHECK. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE GENERATOR. ALSO, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENTS. IT APPEARS THAT HEMOSTASIS WAS NOT ADEQUATED DURING THE PROCEDURES. THEREFORE, FURTHER IN-SERVICE WORK WAS PERFORMED WITH THE PHYSICIAN TO ADDRESS THE ISSUE. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN PT INCIDENTS. THE ESU WAS USED IN POLYPECTOMY PROCEDURES WHERE BLEEDING OCCURRED. THE BLEEDING WAS CONTROLLED/STOPPED BY USING CLIPS. NO FURTHER CLINICAL ISSUES WITH THE PTS WERE REPORTED. THE UNIT WAS DISTRIBUTED BY OUR PARENT COMPANY TO A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 200D ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention