BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 17785510 · Received September 20, 2023

    Report

    Report Number
    3002808148-2023-10115
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 24, 2023
    Report Date
    November 15, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. CORRECTED FIELDS: D4 (SERIAL NUMBER IS UNKNOWN). ADDITIONAL INFORMATION ADDED TO FIELD H6. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORT COULD NOT BE CONFIRMED. BASED ON THE FACTS OBTAINED FROM THE INVESTIGATION, THE SPECIFIC ROOT CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED AT THIS TIME BECAUSE THE DEVICE WAS NOT RETURNED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL PRODUCT CODES: FDF, FDS THE DEVICE MAY BE RETURNED TO OLYMPUS FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III XENON LIGHT SOURCE HAD WATER SPILLED ON IT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747446 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown