BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 16565464 · Received March 17, 2023

    Report

    Report Number
    9610773-2023-00790
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 25, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH: BERLIN
    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 CONFIRMED THE REPORTED ISSUES DUE TO A DEFECTIVE GENERATOR BOARD. THE DEVICE DISPLAYED ERROR MESSAGE E433, WHICH THE SBC TRACED BACK TO A DEFECTIVE GENERATOR BOARD. POSSIBLE CAUSES OF A DEFECTIVE GENERATOR BOARD: A DEFECTIVE TR1 TRANSFORMER ON THE GENERATOR BOARD (PERMANENT ERROR). A DEFECTIVE CURRENT TRANSFORMER ON THE GENERATOR BOARD (PERMANENT ERROR). A DEFECTIVE IMPEDANCE TRANSFORMER ON THE GENERATOR BOARD (PERMANENT ERROR). A DEFECTIVE PEAK RECTIFIER ON THE GENERATOR BOARD (PERMANENT ERROR). THE OUTPUT VOLTAGE IS TOO LOW DUE TO BAD SWITCHING OF THE HF OUTPUT STAGE ON THE GENERATOR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A GENERATOR (HF UNIT) HAD AN ERROR CODE. THE REPORTED ISSUE WAS FOUND DURING INSPECTION BEFORE USE OF THE DEVICE. THE INTENDED PROCEDURE WAS LAPAROSCOPIC SURGERY. THE FACILITY FINISHED THE PROCEDURE WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548172 HF UNIT "ESG-400" GENERATOR IYD OLYMPUS WINTER & IBE GMBH: BERLIN WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown