BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 14906232 · Received July 4, 2022

    Report

    Report Number
    9610773-2022-00251
    Event Type
    Malfunction
    Date Received
    July 4, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 4, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    UDI-DI
    04042761076838
    PMA / PMN Number
    K203682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS VIETNAM (OVN) (RETURNED TO OVN ON 2022/06/20). THE EVALUATION AT OVN REPAIR CENTER FOUND CRACKS ON THE GENERATOR¿S FRONT PANEL, RUST ON THE COVER AND CONFIRMED THE OCCURRENCE OF ERROR E433. THIS ERROR MESSAGE, WHICH IN THE CASE AT HAND WAS CAUSED BY A DEFECT OF THE GENERATOR BOARD, IS TRIGGERED BY THE GENERATOR¿S SAFETY SYSTEM. IN CASE OF CRITICAL ERRORS, THE SAFETY SYSTEM WILL NOT PERMIT ANY FURTHER USE OF THE GENERATOR UNTIL THE ERROR IS RECTIFIED. THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO COMPONENT FAILURE. THE REPORTED DAMAGE TO THE GENERATOR¿S FRONT PANEL AND THE RUST WAS MOST LIKELY CAUSED BY IMPROPER HANDLING AND CAN THUS BE ATTRIBUTED TO USE ERROR. THERE IS NO CAUSAL RELATIONSHIP TO THE REPORTED ERROR MESSAGE. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE ELECTROSURGICAL GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. IN ADDITION, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE ESG-400 HF GENERATOR ISSUED ERROR MESSAGE E433 AND RESTARTED ITSELF. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401633 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown