BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 15325866 · Received August 31, 2022

    Report

    Report Number
    9610773-2022-00355
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 31, 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 INVESTIGATION/EVALUATION BUT TO OLYMPUS SHANGHAI (OSH) (RETURNED TO OSH ON (B)(6) 2022). THE EVALUATION AT OSH CONFIRMED THE PERMANENT OCCURRENCE OF ERROR E433 AND TRACED THE ERROR 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. . 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. 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 DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE ESG-400 HF GENERATOR ISSUED ERROR MESSAGE E433. HOWEVER, THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614868 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS WA22367A PASSIVE WORKING ELEMENT.