BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 10440813 · Received August 24, 2020

    Report

    Report Number
    8010047-2020-05741
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Report Date
    October 14, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. OLYMPUS LOCAL SERVICE ENGINEER REPORT THAT THE POWER SUPPLY UNIT OF THE DEVICE WAS BROKEN. OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO THE POWER SUPPLY UNIT OF THE DEVICE WAS BROKEN BY SOME CAUSE. THE INSTRUCTION MANUAL OF THE DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS SERVICE OPERATION REPAIR CENTER WAS INFORMED BY THE FACILITY THAT IN UNSPECIFIED TIMING THE SUBJECT DEVICE FAILED TO POWER ON. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906975 VISERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-S190

    Patients

    Seq Age Sex Outcome Treatment
    1