BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 12376078 · Received August 27, 2021

    Report

    Report Number
    9610773-2021-00234
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 29, 2021
    Report Date
    August 27, 2021
    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 · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS (B)(6) (OSH), (RETURNED TO OSH ON 2021-08-04). THE EVALUATION CONFIRMED THE OCCURRENCE OF ERROR MESSAGE E433. THIS ERROR MESSAGE, WHICH IN THIS CASE WAS CAUSED BY A DEFECTIVE HVPS 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. 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 #: WB91051W; BRAND NAME: HF UNIT "ESG-400"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K203682; PRODUCT CODE: GEI.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC INTRAUTERINE ELECTROTOMY PROCEDURE, THE ESG-400 HF-GENERATOR ISSUED ERROR CODE E433. THE INTENDED PROCEDURE WAS 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
    1273445 HF UNIT "ESG-400" HF-GENERATORS GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS VISERA ELITE VIDEO SYSTEM (S190)