BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 15026027 · Received July 15, 2022

    Report

    Report Number
    9610773-2022-00272
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    July 4, 2022
    Report Date
    July 15, 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 2022/07/11). THE EVALUATION AT OSH CONFIRMED THE OCCURRENCE OF ERROR E433. THIS ERROR MESSAGE, WHICH IN THE CASE AT HAND WAS CAUSED BY A DEFECT OF THE GENERATOR BOARD, IS TRIGGERED BY THE GENERATOR¿S SAFETY SYSTEM. IN CASE OF CRITICAL ERRORS, THE SAFETY SYSTEM WILL NOT PERMIT ANY FURTHER USE OF THE GENERATOR UNTIL THE ERROR IS RECTIFIED. THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO COMPONENT FAILURE. HOWEVER, A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE ELECTROSURGICAL GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. 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 OUTSIDE A PROCEDURE A LOANER ESG-400 HF-GENERATOR ISSUED ERROR CODES E433. SINCE THE ERROR OCCURRED OUTSIDE A PROCEDURE, NO PATIENT WAS INVOLVED AND THERE WAS NO ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280518 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown