BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 20363766 · Received October 3, 2024

    Report

    Report Number
    9610595-2024-20038
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    August 19, 2024
    Report Date
    November 6, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170339615
    PMA / PMN Number
    K100584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    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 DEVICE EVALUATION. ADDITIONALLY, TO PROVIDE AN UPDATE TO FIELD H3. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE REPORTED EVENT WAS NOT REPRODUCED. 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, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER: 2429304- 2024-0000432. THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SCREENING COLONOSCOPY, WHEN ANGULATING THE SCOPE, IT WOULD LOCK. THE PHYSICIAN WAS THUS UNABLE TO DISENGAGE DURING REMOVAL OF A POLYP, CAUSING THE COLON TO TEAR. ADDITIONAL INFORMATION REGARDING THE TREATMENT AND OUTCOME OF THE PATIENT WAS REQUESTED MULTIPLE TIMES, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403499 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H180AL 04953170339615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other