BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ESG-100, 100...120 V~,

    MDR report key: 15492869 · Received September 27, 2022

    Report

    Report Number
    9610773-2022-00439
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    September 8, 2022
    Report Date
    September 27, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    UDI-DI
    04042768910463
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEM CORPORATION (OMSC), (B)(6) (RETURNED TO OMSC ON 2022-09-13). THE EVALUATION AT OMSC CONFIRMED THE PERMANENT OCCURRENCE OF ERROR MESSAGE E274 AND TRACED THE ERROR BACK TO A DEFECTIVE CONTROL BOARD. THUS, THE REPORTED EVENT/INCIDENT CAN BE ATTRIBUTED TO COMPONENT FAILURE. ANY ERROR MESSAGES THAT MAY APPEAR DURING OPERATION ARE TRIGGERED BY THE SAFETY SYSTEM OF THE ESG-100 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 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 RESULTS. 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 #: WB991036; BRAND NAME: OLYMPUS ESG-100, 220...240 V~; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K073207; PRODUCT CODE: GEI.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC POLYP EXAMINATION PROCEDURE UNDER SEDATION THAT WAS TO BE TURNED INTO A THERAPEUTIC POLYPECTOMY PROCEDURE IF POLYPS WERE TO BE DISCOVERED, THE ESG-100 ELECTROSURGICAL GENERATOR ISSUED ERROR MESSAGE E274 WHEN IT WAS SWITCHED ON. SINCE NO SPARE GENERATOR WAS AVAILABLE, THE INTENDED PROCDURE WAS CANCELLED AND A FOLLOW-UP PROCEDURE IS TO BE SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273803 OLYMPUS ESG-100, 100...120 V~, HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB991046 04042768910463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other