BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 19999314 · Received August 18, 2024

    Report

    Report Number
    3002808148-2024-07827
    Event Type
    Injury
    Date Received
    August 18, 2024
    Date of Event
    July 29, 2024
    Report Date
    February 3, 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
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION 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 2429304-2024-0000367.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE REPORTED FAILURE (POWER DOES NOT TURN ON, LIGHT KEEPS BLINKING, AND DEVICE DOES NOT WORK) WAS CONFIRMED. 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, IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A POWER SUPPLY UNIT FAILURE. THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO H3 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE MIDDLE OF A DIAGNOSTIC COLONOSCOPY PROCEDURE, THE VIDEO SYSTEM SCREEN IMAGE FLICKERED AND THEN WENT BLANK. TROUBLESHOOTING TO TRY ANOTHER POWER CORD AND ANOTHER POWER OUTLET WAS MADE BUT UNSUCCESSFUL. THE PROCEDURE AND THEN PERFORMED IN ANOTHER ENDOSCOPY CENTER AND ANOTHER DEVICE WAS USED. AS SUCH, A 2-HOUR DELAY OCCURRED, WHEREIN THE PATIENT HAD TO BE AWOKEN AND RE-SEDATED ONCE A NEW MACHINE WAS OPERATIONAL. THE CUSTOMER HAD TO GO TO ANOTHER ENDOSCOPY CENTER TO BORROW A NEW DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992566 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