BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 18272034 · Received December 6, 2023

    Report

    Report Number
    9610773-2023-03527
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 19, 2023
    Report Date
    July 15, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH: BERLIN
    Product Code
    GEI
    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

    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. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO A FAULTY GENERATOR BOARD. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED ALTHOUGH THE SUSPECT MEDICAL DEVICE IS NOT MARKETED IN THE USA. HOWEVER, A SIMILAR DEVICE IS MARKETED. MODEL # WB91051W/ CATALOG # WB91051W. BRAND NAME: HIGH FREQUENCY UNIT, ESG-400. COMMON DEVICE NAME: ELECTROSURGICAL SYSTEM GENERATOR. 510(K): K203682. PRODUCT CODE: GEI. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION FOUND THE DEVICE DISPLAYED ERROR CODE E433 DUE TO A DEFECTIVE GENERATOR BOARD. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE HF UNIT "ESG-400" DISPLAYED ERROR CODE (INTERNAL SOFTWARE OR HARDWARE ERROR). THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159293 HF UNIT "ESG-400" ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI OLYMPUS WINTER & IBE GMBH: BERLIN WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown