BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 11549269 · Received March 23, 2021

    Report

    Report Number
    9610773-2021-00101
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    April 1, 2021
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    UDI-DI
    04042761076838
    PMA / PMN Number
    K141225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION BUT TO OLYMPUS IBERIA (OIB). THE EVALUATION/INVESTIGATION AT OIB FOUND CRACKS ON THE GENERATOR¿S FRONT PANEL AND 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. THE REPORTED DAMAGE TO THE GENERATOR¿S FRONT PANEL WAS MOST LIKELY CAUSED BY IMPROPER HANDLING AND CAN THUS BE ATTRIBUTED TO USE ERROR. THERE IS NO CAUSAL RELATIONSHIP TO THE REPORTED ERROR MESSAGE. 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. IN ADDITION, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC UROLOGICAL RESECTION PROCEDURE AT AN UNKNOWN DATE USING A BIPOLAR RESECTOSCOPE, THE ESG-400 HF GENERATOR ISSUED ERROR MESSAGE E433. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED USING A MONOPOLAR RESECTOSCOPE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454636 HF UNIT "ESG-400" HF-GENERATOR GEI OLYMPUS WINTER & IBE GMBH WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1