BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 17840941 · Received September 29, 2023

    Report

    Report Number
    9610773-2023-02753
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 7, 2023
    Report Date
    July 2, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
    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 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 CUSTOMER'S ALLEGATION WAS CONFIRMED. THE EVALUATION FOUND ERROR CODE E433 DUE TO A DEFECTIVE GENERATOR BOARD. FURTHERMORE, THE FOLLOWING ADDITIONAL ISSUES WERE IDENTIFIED DURING INSPECTION: THE TOUCH SCREEN IS DEFECTIVE, AND A CRACKED FRONT PANEL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE DEFECTIVE GENERATOR BOARD COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH FREQUENCY UNIT "ESG-400" DISPLAYED ERROR CODE E433. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345062 HF UNIT "ESG-400" GENERATOR GEI OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown S190