BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 15985618 · Received December 15, 2022

    Report

    Report Number
    9610773-2022-00656
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Report Date
    December 15, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION BUT TO OLYMPUS (B)(4) (RETURNED TO OSH ON 2022/11/21). THE EVALUATION AT OIB CONFIRMED THE OCCURRENCE OF ERROR E433, WHICH COULD NOT BE REPRODUCED, BUT WAS FOUND IN THE ERROR LOG. 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. SINCE THE ERROR MESSAGE COULD NOT BE REPRODUCED, A TEMPORARY FAULT IS ASSUMED. HOWEVER, THE EXACT CAUSE FOR THE OCCURRENCE OF THE ERROR MESSAGE COULD NOT BE DETERMINED IN THIS CASE. THE EVALUATION ALSO FOUND CRACKS IN THE GENERATORS FRONT PANEL AND A MISSING RUBBER FOOD. THIS DAMAGES WERE 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 AN INSPECTION ERROR MESSAGE E433 WAS FOUND IN THE ERROR LOG OF A LOANER ESG-400 HF GENERATOR. 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
    1440000 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown