BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 20321574 · Received September 27, 2024

    Report

    Report Number
    3002808148-2024-09318
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    September 11, 2024
    Report Date
    November 6, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170414596
    PMA / PMN Number
    K222861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND TO PROVIDE AN UPDATE TO FIELD D8. 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. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONFIRMED THAT THERE WAS A MISTAKE IN THE CABLE WIRING. THEREFORE, IT IS PRESUMED THAT DELAY OCCURRED IN THE PROCEDURE AND PHENOMENON ¿PIP IMAGE IS NOT DISPLAYED¿ OCCURRED BECAUSE THE CABLE WIRING WAS INCORRECT. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: -REFERENCE: EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 INSTRUCTIONS (CHAPTER 3 INSTALLATION AND CONNECTION_3.1 PRECAUTIONS FOR INSTALLATION AND CONNECTION_CAUTION_P49) "PROPERLY AND SECURELY CONNECT ALL CABLES. IF THE CABLE CONNECTOR HAS CONNECTION SCREWS, TIGHTEN UP THE SCREWS, LOCK THE CABLE CONNECTOR. OTHERWISE, EQUIPMENT DAMAGE OR MALFUNCTION MAY RESULT." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000424.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER DID NOT PRODUCE A PICTURE IN PICTURE IMAGE. THE ISSUE WAS OBSERVED BY THE SURGEON DURING PREPARATION FOR USE IN A DIAGNOSTIC BRONCHOSCOPY WITH FLUOROSCOPIC GUIDANCE WHILE THE PATIENT WAS ALREADY ON THE TABLE. TROUBLESHOOTING WAS PERFORMED AND THE IMAGE WAS ABLE TO BE VIEWED. THE PROCEDURE WAS COMPETED USING THE SAME DEVICE WITH A 40-MINUTE PRE-PROCEDURAL DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739543 EVIS X1 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-1500 04953170414596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other EVIS EUS ENDOSCOPIC ULTRASOUND CENTER