BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 15678694 · Received October 27, 2022

    Report

    Report Number
    9610773-2022-00507
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 18, 2022
    Report Date
    October 27, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS SHANGHAI (OSH), (RECEIVED AT OSH ON 2022-10-24). THE EVALUATION AT OSH CONFIRMED THE OCCURRENCE OF ERROR MESSAGE E433 AND TRACED THE ERROR BACK TO A DEFECTIVE GENERATOR BOARD. THUS, THE REPORTED EVENT/INCIDENT CAN BE ATTRIBUTED TO COMPONENT FAILURE. ANY ERROR MESSAGES THAT MAY APPEAR DURING OPERATION ARE TRIGGERED BY THE SAFETY SYSTEM OF THE ESG-400 AND COMMUNICATED VISUALLY AND ACOUSTICALLY TO THE USER. THEY ARE PART OF THE DEVICE'S OWN SECURITY CONCEPT. IN PARTICULARLY CRITICAL CASES, FURTHER USE OF THE DEVICE IS PREVENTED BY THE SECURITY SYSTEM UNTIL THE ERROR HAS BEEN CORRECTED. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE HF-GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS. PLEASE NOTE: THIS REPORT IS BEING SUBMITTED ALTHOUGH THE SUSPECT MEDICAL DEVICE IS NOT MARKETED IN THE USA. HOWEVER, A SIMILAR DEVICE IS MARKETED. MODEL # / CATALOG #: WB91051W; BRAND NAME: ELECTROSURGICAL GENERATOR "ESG-400"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K203682; PRODUCT CODE: GEI.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT THE ESG-400 ELECTROSURGICAL GENERATOR ISSUED ERROR MESSAGE E433. NO PATIENT/PROCEDURE WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2944860 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown