BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 21322642 · Received February 6, 2025

    Report

    Report Number
    3002808148-2025-01848
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 10, 2025
    Report Date
    April 17, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS CONSERVATIVELY CLASSIFIED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00066. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. UPDATED FIELDS: H2, H6, H10 AND H11. CORRECTIONS TO B1, B2, AND H1. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, THERE IS NO EVIDENCE THE PATIENT SUFFERED ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THUS, CORRECTING B1, B2, AND H1. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT, AND B2 SHOULD NOT BE MARKED AT ALL. H1 SHOULD ALSO NOT BE MARKED. THE H6 MEDICAL DEVICE PROBLEM REPORTED, AND OTHER FINDINGS WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND HOWEVER THE COMPLAINT WAS CONFIRMED THROUGH REMOTE TROUBLESHOOTING. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AND THE CAUSE WAS NOT ESTABLISHED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00066-01.

    Description of Event or Problem · 0

    DURING SEDATION OF A DIAGNOSTIC COLONOSCOPY THERE WAS A GREATER THAN 30 MINUTE PROLONGATION DUE TO THE PROCESSOR PRINTING BLACK IMAGES. THE IMAGE WAS FINE ON THE MONITOR. THE SYSTEM SET UP WAS CHANGED FROM MEMORY TO HIGH DEFINITION (HD) AND STANDARD DEFINITION (SD) AND IMAGES WERE THEN ABLE TO BE PRINTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919949 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