BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 16129975 · Received January 10, 2023

    Report

    Report Number
    9610773-2023-00151
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 15, 2022
    Report Date
    June 27, 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
    VM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION BUT TO AN OLYMPUS MEDICAL SYSTEMS VIETNAM CO.,LTD. (OVN) REPAIR CENTER (RETURNED TO OVN ON 2022/12/15. DURING THE EVALUATION AT OVN, THE HF GENERATOR ISSUED ERROR MESSAGE E433, WHICH WAS TRACED BACK TO A DEFECTIVE HVPS BOARD. THUS, THIS INCIDENT WAS 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. THE PROBLEM REPORTED BY THE USER THAT THE DEVICE DOES NOT RESPOND AFTER PRESSING THE POWER SWITCH IS MOST PROBABLY THE RESULT OF ERROR MESSAGE E433, SINCE IN THIS CASE THE DEVICE CAN NO LONGER BE STARTED NORMALLY. 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.

    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).

    Description of Event or Problem · 0

    THE ESG-400 ELECTROSURGICAL GENERATOR WAS RETURNED TO OLYMPUS FOR REPAIR WITH THE CUSTOMER REPORTING THAT THE DEVICE DOES NOT RESPOND WHEN THE POWER SWITCH IS PRESSED. DURING THE INSPECTION, THE HF-GENERATOR WAS FOUND TO ISSUE ERROR MESSAGE E433. THERE IS NO INDICATION THAT ANY OF THE FAILURES OCCURED 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
    188958 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATOR GEI OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown