BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 19806390 · Received July 23, 2024

    Report

    Report Number
    3002808148-2024-06710
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    June 26, 2024
    Report Date
    February 4, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 H4. 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, THE SUBJECT DEVICE WAS NOT RETURNED, AND AN SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED WITH THE INFORMATION RECEIVED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER AND LIGHT SOURCE DISPLAYED ERROR CODES B30 AND E216 (SCOPE COMMUNICATION ERRORS) WHEN THE COLONOVIDEOSCOPE WAS USED DURING A PROCEDURE. OLYMPUS TECHNICAL ASSISTANCE CENTER PROVIDED TROUBLESHOOTING STEPS AND UPON FURTHER FOLLOW-UP, THE CUSTOMER REPORTED THAT THE PROBLEM WAS NARROWED DOWN TO A SINGLE SCOPE. THE ISSUE APPEARED RESOLVED ALTHOUGH SPECIFICS WERE NOT SUPPLIED. IT WAS ADDITIONALLY REPORTED THAT THE PROCEDURE PERFORMED WAS A COLONOSCOPY AND THAT THE SCOPE SHOT ERROR MESSAGES AS SOON AS IT WAS TURNED ON. OTHER SCOPES WERE USED AFTER THE FIRST SCOPE GAVE AN ERROR, BUT THE CODE STILL SHOWED. AFTER HOOKING UP A SCOPE THAT USED THE PIG TAIL ATTACHMENT, IT BEGAN TO WORK. THE USER WENT BACK TO ONE OF THE OTHER SCOPES USED AND IT ALSO WORKED. THE PROCEDURE WAS DELAYED A LITTLE OVER AN HOUR WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS COMPLETED AFTER THE ISSUE WAS RESOLVED USING A DIFFERENT SCOPE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934966 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other