BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 12408449 · Received September 1, 2021

    Report

    Report Number
    8010047-2021-11092
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 6, 2021
    Report Date
    October 13, 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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. E103 INDICATES A LAMP IGNITION FAILURE. BASED ON THE RESULTS OF THE INVESTIGATION, THE LAMP FAILED TO IGNITE BECAUSE A NON-OLYMPUS LAMP WAS USED OR AGING OF IGNITER BOARD OR LAMP ITSELF MAY INTERFERE THE LAMP IGNITION BECAUSE MORE THAN 9 YEARS HAD PASSED SINCE THE DEVICE WAS PURCHASED. ADDITIONALLY, THE USER INSTALLED THE LAMP WITHOUT NOTICING (OR FOLLOWING) THE DESCRIPTION IN THE INSTRUCTION MANUAL. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "NEVER INSTALL A LAMP THAT HAS NOT BEEN APPROVED BY OLYMPUS. THE USE OF A NONAPPROVED LAMP CAN CAUSE DAMAGE TO THE LIGHT SOURCE AND ANCILLARY EQUIPMENT, MALFUNCTION OR A FIRE." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) SUPPORT SPOKE TO THE CUSTOMER TO TROUBLESHOOT THE DEVICE. THE CUSTOMER MENTIONED THAT THE LAMP TURNED OFF MOMENTARILY AND TURNED BACK ON. FURTHERMORE, THE OPERATOR OF THE UNIT STEERED THE POWER AND THE ERROR CLEARED. THE LIGHT SOURCE WAS OPERATING AS NORMAL AT THE TIME OF CALL. TAC REFERENCED THE OTV-S190 TECHNICAL GUIDE ON ES-WEB. TAC MENTIONED TO THE CUSTOMER THAT THE THIRD PARTY STORZ MAIN LAMP WAS INSTALLED CORRECTLY HOWEVER, AN OLYMPUS BRAND LAMP WAS RECOMMENDED. TAC ADVISED THE CUSTOMER TO EXCHANGE THE PROCESSOR OR LIGHT SOURCE WITH A KNOWN GOOD DEVICE TO HELP ISOLATE THE ISSUE FURTHER. A FOLLOW UP WAS MADE AND THE CUSTOMER CONFIRMED THAT THE DEVICE WAS OPERATING PROPERLY. 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 · 0

    THE CUSTOMER REPORTED THE VISERA ELITE XENON LIGHT SOURCE DISPLAY AN E103 ERROR MESSAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302594 VISERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-S190 04953170301995

    Patients

    Seq Age Sex Outcome Treatment
    1