BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 12348619 · Received August 20, 2021

    Report

    Report Number
    8010047-2021-10531
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 26, 2021
    Report Date
    September 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THE LEGAL MANUFACTURER PERFORMED AN INVESTIGATION. THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY SPECIFIED. IT WAS LIKELY THE LAMP WAS DIFFICULT TO TURN ON DUE TO THE AGE OF THE LAMP LIGHT OR IT WAS CAUSED BY TEMPORARY MALFUNCTION OF THE IGNITER.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CUSTOMER REPORT OF THE DEVICE DISPLAYING AN E103 ERROR MESSAGE AND LIGHT ILLUMINATION GOING TO THE SPARE LAMP WAS NOTED BY THE ENDOSCOPY ACCOUNT MANAGER (EAM). THE EAM ADVISED THE CUSTOMER TO PRESS THE RESET BUTTON AND THE ISSUE RESOLVED. 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

    IT WAS REPORTED BY THE CUSTOMER, THE EVIS EXERA III XENON LIGHT SOURCE DISPLAYED AN E103 ERROR MESSAGE AT THE BEGINNING OF A PROCEDURE. THE DEVICE WAS INSPECTED BEFORE USE AND HAD RECENTLY BEEN SERVICED BY OLYMPUS. PRIOR TO USE THE DEVICE WAS WORKING "FINE." THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AND NO OTHER DEVICES WERE INVOLVED IN THE EVENT. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT/USER INJURY OR HARM REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247334 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1