BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 16122121 · Received January 9, 2023

    Report

    Report Number
    9610773-2023-00136
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 11, 2022
    Report Date
    June 26, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
    Product Code
    GEI
    UDI-DI
    04042761076838
    PMA / PMN Number
    K203682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER EIGHT YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT A DEFECTIVE GENERATOR BOARD LED TO THE MALFUNCTION. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS ISSUE IS ADDRESSED IN A PRODUCT QUALITY INFORMATION (PQI), PUBLISHED ON 28FEB2020. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. IN ADDITION, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION: MINOR DUST INSIDE THE UNIT; VOLUME KNOB IS MISSING HENCE NEEDS TO FIX NEW; HEAVY SCRATCHES FOUND ON THE FRONT PANEL. A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE GENERATOR WAS DISPLAYING AN ERROR CODE (E433). WHILE ONSITE, THE OLYMPUS FIELD SERVICE ENGINEER CHECKED THE EQUIPMENT AND FOUND IT WAS RESTARTING AUTOMATICALLY AND DISPLAYED ERROR CODE E433. THE MALFUNCTION WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING SIMILAR DEVICE. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510910 HF UNIT "ESG-400" ELECTROSURGICAL GENERATOR ESG-400 GEI OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051W 04042761076838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown