BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 19079762 · Received April 10, 2024

    Report

    Report Number
    3002808148-2024-03351
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 2, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170301995
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) ADVISED THE CUSTOMER THAT THEY SHOULD NOT USE THE LIGHT SOURCE SINCE THE MAIN LAMP HAS FAILED. THE CUSTOMER STATED THAT THE SALE REPRESENTATIVE WILL VISIT THEM TO HELP THEM TROUBLESHOOT THE ISSUE. THE ISSUE WAS RESOLVED DURING ONSITE VISIT BY SALES REPRESENTATIVE AND THE LIGHT SOURCE WAS REPLACED. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION FIELDS: D9. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5, D8, H3, H4 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. AN OLYMPUS FIELD SERVICE REPRESENTATIVE (FSE) VISITED THE SITE AND CONFIRMED THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED; HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE MALFUNCTION WOULD LIKELY BE A FAULTY LAMP. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE XENON LIGHT SOURCE EXHIBITED ERROR E103 (IGNITION ERROR) AND THERE WERE NO LIGHT COMING OUT OF THE DISTAL END. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    THE REPORTED EVENT OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407170 VISERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-S190 04953170301995

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown