BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 16003513 · Received December 19, 2022

    Report

    Report Number
    9610773-2022-00684
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Report Date
    June 26, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
    Product Code
    GEI
    UDI-DI
    04042761076838
    PMA / PMN Number
    K203682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION BUT TO OLYMPUS IBERIA (OIB) (RETURNED TO OIB ON 2022/12/01). THE EVALUATION AT OIB FOUND CRACKS ON THE GENERATOR¿S FRONT PANEL AND TOP COVER AND CONFIRMED THE OCCURRENCE OF ERROR MESSAGE E433, WHICH COULD NOT BE REPRODUCED, BUT WAS FOUND IN THE ERROR LOG. 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. SINCE THE ERROR MESSAGE COULD NOT BE REPRODUCED, A TEMPORARY FAULT IS ASSUMED. HOWEVER, THE EXACT CAUSE FOR THE OCCURRENCE OF THE ERROR MESSAGE COULD NOT BE DETERMINED IN THIS CASE. THE REPORTED DAMAGE TO THE GENERATOR¿S FRONT PANEL AND TOP COVER 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 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 RESULT.

    Additional Manufacturer Narrative · 0

    CORRECTION: D3, G1, H11. THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING MAINTENANCE OF A LOANER ESG-400 HF-GENERATOR ERROR E433 WAS FOUND IN THE ERROR LOG. THERE IS NO INDICATION THAT ERROR MESSAGE E433 OCCURRED DURING A PROCEDURE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747955 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown