BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 16414856 · Received February 21, 2023

    Report

    Report Number
    3002808148-2023-01627
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    January 20, 2023
    Report Date
    April 21, 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
    MA, US
    Reporter Occupation
    003

    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 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE LOCKING MECHANISM NOT FUNCTIONING OCCURRED DUE TO A FAULTY SCOPE SOCKET. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE (IFU): ¿WARNINGS AND CAUTIONS CAUTIONS DO NOT APPLY EXCESSIVE FORCE TO THE LIGHT SOURCE AND/OR OTHER INSTRUMENTS CONNECTED. OTHERWISE, DAMAGE AND/OR MALFUNCTION CAN OCCUR. DO NOT POSITION THE MEDICAL DEVICE SO THAT IT IS DIFFICULT TO DISCONNECT FROM THE WALL OUTLET (MAINS POWER SUPPLY). CHAPTER 6 LAMP REPLACEMENT 6.1 REPLACEMENT OF THE EXAMINATION (XENON) LAMP. ALWAYS USE THE EXAMINATION LAMP DESIGNATED BELOW. TO ORDER A NEW EXAMINATION LAMP, CONTACT OLYMPUS. XENON LAMP MAJ-1817¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE ALLEGATION WAS CONFIRMED. THERE WAS A FAULTY SCOPE SOCKET. THE SCOPE CONNECTOR LOCKING MECHANISM WAS NOT FUNCTIONING. WHEN THE SCOPE WAS DISCONNECTED, THE LOCKING MECHANISM REMAINED ENGAGED. IN ADDITION, THE FRONT PANEL WAS BROKEN BELOW THE SCOPE CONNECTOR. THE POWER SWITCH WAS UPDATED. A NON-OLYMPUS LAMP LIFE METER WITH 0 OR MORE HOURS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    AN OLYMPUS ONSITE IMPLEMENTATION SPECIALIST REPORTED ON BEHALF OF THE CUSTOMER, THE EVIS EXERA III XENON LIGHT SOURCE OUTPUT CONNECTOR WAS BROKEN AND COULD NOT CONNECT. A SCOPE BROKE THE INNER COUPLER OF CONNECTOR. THE EVENT OCCURRED WHILE A BED WAS MOVING UP. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667119 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