BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 16084874 · Received January 3, 2023

    Report

    Report Number
    9610773-2023-00046
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 5, 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
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS AUSTRALIA PTY LTD. AND OLYMPUS NEW ZEALAND LIMITED (OAZ), (RETURNED TO OAZ ON 2022-12-05). DURING THE EVALUATION AT OAZ, THE REPORTED ERROR MESSAGES E433 AND E172 WERE FOUND IN THE ERROR LOG BUT COULD NOT BE REPRODUCED. SINCE THE ERROR MESSAGES COULD NOT BE REPRODUCED, TEMPORARY FAULTS ARE ASSUMED. HOWEVER, THE EXACT CAUSE FOR THE OCCURRENCE OF THE ERROR MESSAGES COULD NOT BE DETERMINED IN THIS CASE. 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 MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE 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 FROM 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.

    Description of Event or Problem · 0

    THE DEMO ESG-400 ELECTROSURGICAL GENERATOR WAS REPORTED TO HAVE ISSUED ERROR MESSAGES E433 AND E172 DURING MAINTENANCE. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153244 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown