BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR "ESG-400"

    MDR report key: 15101200 · Received July 26, 2022

    Report

    Report Number
    9610773-2022-00296
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    July 8, 2022
    Report Date
    July 26, 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 EVALUATION/INVESTIGATION BUT TO AN OLYMPUS REGIONAL REPAIR CENTER (RRC) IN CHINA (RETURNED TO RRC ON 2022-07-14). THE EVALUATION CONFIRMED THE OCCURRENCE OF ERROR MESSAGE E433 WHICH 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. IN THE CASE AT HAND, THIS WAS CAUSED BY A DEFECTIVE GENERATOR BOARD AND MOTHERBOARD. THUS, THIS EVENT/INCIDENT WAS ATTRIBUTED TO COMPONENT FAILURE. 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, BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, 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 #: 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 A PROSTATECTOMY PROCEDURE, THE ELECTROSURGICAL GENERATOR 'ESG-400' DISPLAYED ERROR MESSAGE E433 AND COULD NO LONGER BE USED. HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED WITHOUT A DELAY WITH 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
    572637 ELECTROSURGICAL GENERATOR "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male OLYMPUS VISERA ELITE VIDEO PROCESSOR (OTV-S190)