BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 16450300 · Received February 27, 2023

    Report

    Report Number
    9610773-2023-00588
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    January 28, 2023
    Report Date
    July 10, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
    Product Code
    IYD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS. DURING THEIR INSPECTION, THE SBC ATTRIBUTED THE ERROR TO A DEFECTIVE HIGH VOLTAGE POWER SUPPLY (HVPS) BOARD AND A DEFECTIVE GENERATOR BOARD. ERROR E433 IS TRIGGERED BY THE DEVICE¿S SAFETY SYSTEM AND OCCURS IF THE EFFECTIVE VALUE OF THE OUTPUT SIGNAL WHICH IS SET FOR TESTING FALLS BELOW THE INTENDED LIMIT OF 130V. POSSIBLE CAUSES FOR THE OCCURRENCE OF THE ERROR MESSAGE E433 ARE: 1. DISTURBANCE OF THE ESG-400 DUE TO INTERSPERSED ELECTROMAGNETIC INTERFERENCE FIELDS (TEMPORARY ERROR). 2. THE USER ACTUATES THE FOOT SWITCH WHILE THE GENERATOR IS BOOTING (TEMPORARY ERROR CAUSED BY USER ACTION). 3. A DEFECTIVE FOOT SWITCH DUE TO A SHORT CIRCUIT IN THE CONNECTOR (TEMPORARY ERROR). THIS CASE WAS ADDRESSED BY CAPA 147P-017, IMPLEMENTED ON 30.03.2015. 4. A DEFECTIVE FOOT SWITCH DUE TO A DEFECTIVE REED CONTACT (TEMPORARY ERROR). 5. A DEFECTIVE CABLE CONNECTION BETWEEN THE HVPS BOARD AND THE GENERATOR BOARD (TEMPORARY OR PERMANENT ERROR). 6. A DEFECTIVE CABLE CONNECTION FOR THE OUTPUT SIGNAL BETWEEN THE GENERATOR BOARD AND THE RELAY BOARD (TEMPORARY OR PERMANENT ERROR). 7. A DEFECTIVE TR1 TRANSFORMER ON THE GENERATOR BOARD (PERMANENT ERROR). 8. A DEFECTIVE CURRENT TRANSFORMER ON THE GENERATOR BOARD (PERMANENT ERROR). 9. A DEFECTIVE IMPEDANCE TRANSFORMER ON THE GENERATOR BOARD (PERMANENT ERROR). 10. A DEFECTIVE PEAK RECTIFIER ON THE GENERATOR BOARD (PERMANENT ERROR). 11. THE SUPPLY VOLTAGE FROM THE HVPS BOARD IS MISSING OR TOO LOW (PERMANENT ERROR). 12. THE OUTPUT VOLTAGE IS TOO LOW DUE TO BAD SWITCHING OF THE HF OUTPUT STAGE ON THE GENERATOR BOARD (PERMANENT ERROR). 13. A DEFECTIVE HVPS BOARD DUE TO A SHORT CIRCUIT OF THE MOS TRANSISTORS (PERMANENT ERROR). 14. A DEFECTIVE MOTHERBOARD DUE TO A SHORT CIRCUIT OF THE NTC1 RESISTOR (PERMANENT ERROR). 15. A DEFECTIVE MOTHERBOARD DUE TO A DEFECTIVE ADC (PERMANENT ERROR). 16. DEFECTIVE TVS DIODES ON THE RELAY BOARD (PERMANENT ERROR). A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT AN HF UNIT HAD AN E433 ERROR. THE REPORTABLE EVENT WAS FOUND DURING INSPECTION OF THE DEVICE. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752304 HF UNIT "ESG-400" GENERATORS IYD OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown