BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 16574463 · Received March 20, 2023

    Report

    Report Number
    9610773-2023-00813
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 20, 2023
    Report Date
    June 26, 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

    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. DURING THEIR INSPECTION, THE SBC FOUND THAT THE HAND SWITCH FUNCTION AT THE MONOPOLAR 1 OUTPUT WAS NOT WORKING. THE SBC TRACED THIS ISSUE BACK TO A DEFECTIVE MOTHERBOARD. FINALLY, THE SBC FOUND THE CONTACTS OF THE MONOPOLAR 1 CONNECTION SOCKET OF THE FRONT PANEL TO BE CORRODED. THE SBC DID NOT DETAIL IF THERE WAS AN ELECTRICAL OR FUNCTIONAL IMPAIRMENT. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. 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. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A GENERATOR (HF UNIT) HAD AN E433 ERROR. THE PATIENT WAS NOT UNDER SEDATION AND THERE WAS NO DELAY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649689 HF UNIT "ESG-400" GENERATOR IYD OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown