BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 18167058 · Received November 19, 2023

    Report

    Report Number
    9610773-2023-03337
    Event Type
    Malfunction
    Date Received
    November 19, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 19, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    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 OCCASIONALLY REPORTED E006 DUE TO A DEFECTIVE MOTHERBOARD, AND THE OUTPUT VALUE OF UNIPOLAR CONDENSATION WAS LOW DUE TO A DEFECTIVE GENERATOR BOARD. THE INVESTIGATION IS ONGOING. 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 HIGH FREQUENCY UNIT "ESG-400" DISPLAYED ERROR CODE E006. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637064 HF UNIT "ESG-400" ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI OLYMPUS WINTER & IBE GMBH WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown WA22367A.