BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 12288366 · Received August 6, 2021

    Report

    Report Number
    8010047-2021-09913
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 12, 2021
    Report Date
    September 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    UDI-DI
    04953170301995
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE THE RESULT OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE SUBJECT DEVICE WAS REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS. THE LEGAL MANUFACTURER PERFORMED AN INVESTIGATION, A CONCLUSIVE ROOT CAUSE WAS NOT IDENTIFIED. THE INVESTIGATION DETERMINED THE XENON LAMP ENDED ITS LIFE AFTER THE REGULAR USE, THERE WAS NO DEVICE ERROR. THE LAMP HOUR REACHED 500 HOURS AND SPARE LAMP TURNED ON.

    Additional Manufacturer Narrative · 1

    THE OLYMPUS REPRESENTATIVE (REP) CALLED TO SPEAK WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) ON BEHALF OF THE CUSTOMER TO TROUBLESHOOT THE DEVICE. THE REP REPORTED THAT THE DEVICE BULB HAS REACHED THE 500 HOURS LIMIT AND THE SPARE LAMP WAS ON. THE REP REQUESTED FOR THE BULB PART NUMBER FOR REPLACEMENT AND IF THE CUSTOMER COULD USE THE DEVICE WITH THE SPARE LIGHT. TAC INSTRUCTED THAT THE DEVICE COULD NOT BE USED WITH THE SPARE LIGHT ON. ADDITIONALLY, TAC EMAILED THE BULB PART NUMBER AND THE QRG TO THE REP. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED TO OLYMPUS THAT THE VISERA ELITE XENON LIGHT SOURCE PRODUCE AN ERROR CODE E102. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185436 VISERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-S190 04953170301995

    Patients

    Seq Age Sex Outcome Treatment
    1