BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR ESG-400

    MDR report key: 15154764 · Received August 3, 2022

    Report

    Report Number
    9610773-2022-00314
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Report Date
    September 8, 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
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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 2022/07/22). THE EVALUATION AT OIB FOUND THE FOOT SWITCH SOCKET TO BE BROKEN AND CONFIRMED THE PERMANENT OCCURRENCE OF ERROR E433, WHICH WAS TRACED BACK TO A DEFECTIVE GENERATOR BOARD. THUS, THE REPORTED 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. THE REPORTED DAMAGE TO THE GENERATOR¿S FOOT SWITCH SOCKET 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 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 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.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING OR OUTSIDE A PROCEDURE AT AN UNKNOWN DATE, THE ELECTROSURGICAL GENERATOR "ESG-400" DISPLAYED ERROR MESSAGE E433. 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
    1903685 ELECTROSURGICAL GENERATOR ESG-400 HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown