BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 17547485 · Received August 14, 2023

    Report

    Report Number
    9610773-2023-02239
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 27, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH: BERLIN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 NOT RETURNED TO OLYMPUS FOR EVALUATION AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    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 (B)(4).

    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, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED ALTHOUGH IT CAN BE PRESUMED IT WAS DUE TO FAILURE OF MOTHERBOARD. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE HF UNIT "ESG-400" DISPLAYED ERROR CODE E006 DURING A THERAPEUTIC, TRANS URETHRAL RESECTION OF BLADDER TUMOUR PROCEDURE. THE ERROR EVENTUALLY STOPPED OCCURRING AND THE TREATMENT WAS CONTINUED AND COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197836 HF UNIT "ESG-400" GENERATOR GEI OLYMPUS WINTER & IBE GMBH: BERLIN WB91051J B001589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown