BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT SWITCH, DOUBLE, FOR, ESG-400

    MDR report key: 20453424 · Received October 15, 2024

    Report

    Report Number
    9610773-2024-02518
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 16, 2024
    Report Date
    April 10, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    UDI-DI
    04042761076807
    PMA / PMN Number
    K203682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE CUSTOMER'S ALLEGATION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: DAMAGE TO THE FOOT SWITCH. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO MFR 3003724334 - 2024 - 00388 (1/2).

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FOOT SWITCH OF THE ELECTROSURGICAL GENERATOR HAD AN ERROR CODE E433. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36138 FOOT SWITCH, DOUBLE, FOR, ESG-400 WB50402W GEI OLYMPUS WINTER & IBE GMBH WB50402W 04042761076807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown WB91051W - HF GENERATOR