BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 18897691 · Received March 13, 2024

    Report

    Report Number
    3002808148-2024-02392
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    March 4, 2024
    Report Date
    August 5, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND THE EVALUATION FOUND NO REPORTABLE MALFUNCTIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER REGARDING THE REPORTED EVENT AS WELL AS CORRECTIONS. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B1, B2, B5, H1, AND H6. CORRECTIONS WERE MADE TO THE FOLLOWING FIELDS: E2, E3, AND G2. THIS REPORT WAS SUBMITTED BY THE IMPORTER UNDER THE IMPORTER'S REPORT NUMBER 2429304-2024-0000273.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS EVALUATED BY OLYMPUS. AND THE REPORTED PHENOMENON WAS NOT REPRODUCED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED WITH THE INFORMATION RECEIVED. THE EVENT CAN BE DETECTED/PREVENTED, BY FOLLOWING THE INSTRUCTIONS FOR USE, WHICH STATE: CHAPTER 9: TROUBLESHOOTING, 9.2: TROUBLESHOOTING GUIDE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIGHT SOURCE WAS SHOWING A B30 (SCOPE COMMUNICATION ERROR) ERROR CODE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE ISSUE OCCURRED AT THE BEGINNING OF A DIAGNOSTIC COLONOSCOPY. THERE WAS A 30-MINUTE DELAY TO SWITCH OUT EQUIPMENT WHILE THE PATIENT WAS UNDER DEEP SEDATION. THE PROCEDURE WAS THEN COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO COMPLICATIONS FROM THE PROLONGED ANESTHESIA AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018568 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other