BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 20075636 · Received August 27, 2024

    Report

    Report Number
    3002808148-2024-08173
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 2, 2024
    Report Date
    October 21, 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
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALLED THE TECHNICAL ASSISTANCE CENTER (TAC) FOR TROUBLESHOOTING. FOR THE E402 ERROR CODE, TAC ADVISED TO RESEAT THE CABLING. AFTER DOING SO, NO E402 ERROR OCCURRED. FOR THE E955 ERROR CODE, TAC ADVISED THE CUSTOMER TO RE-ENTER THE PATIENT INFORMATION. AFTER DOING SO, THE E955 ERROR CODE NO LONGER OCCURRED. TAC ADVISED THAT THE E402 ERROR CODE USING THE MAJ-1916 CAN GLITCH. SWITCHING TO THE P-EMULATOR CABLE WOULD HELP IN NOT GETTING THE ERROR AS OFTEN. TAC ALSO ADVISED TO HAVE THE PROVATION SYSTEM RUNNING BEFORE TURNING ON THE VIDEO SYSTEM CENTER. 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 2429304-2024-0000390.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) FURTHER INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, NO FURTHER INFORMATION COULD BE OBTAINED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DIAGNOSTIC COLONOSCOPY WITH POLYPECTOMY THE VIDEO SYSTEM CENTER HAD ISSUES WITH PROVATION AFTER UPGRADING AND AN ERROR E955 AND E402 OCCURRED. THE PATIENT WAS UNDER ANESTHESIA WHEN THE WHEN THE ERROR CODES APPEARED AND WAS MOVED TO THE NEXT ROOM WITH THE SAME ERROR CODES HAPPENING. THE USER CONTINUED TO TROUBLESHOOT THE PROBLEM. IT WAS THEN DECIDED TO CONTINUE THE PROCEDURE WITHOUT PICTURES. AS SOON AS THE PROCEDURE WAS STARTED THE SYSTEM STARTED WORKING. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE ISSUE DELAYED THE PROCEDURE AND EXTENDED THE PATIENT'S ANESTHESIA FOR 30 MINUTES. THERE WAS NO FURTHER PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941614 EVIS X1 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-1500 04953170414596

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other DF CABLE.| MAJ-1916 COMMUNICATION CONVERTER (SN (B)(6)).| MAJ-1916 COMMUNICATION CONVERTER (SN (B)(6)).| MAJ-1918 INTERFACE CONVERTER CABLE.| PROVATION.