BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16731207 · Received April 13, 2023

    Report

    Report Number
    2429304-2023-00065
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    February 25, 2023
    Report Date
    July 6, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE FOR THE SUBJECT DEVICE FROM FDF TO FDS. SEE SECTION D2.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC MUCOSAL RESECTION OF A NODULE, RESECTION WAS COMPLICATED BY POST RESECTION HEMORRHAGE. THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE USED IN THIS CASE COULD NOT ADEQUATELY RETROFLEX, THUS RESULTING IN PROLONGED BLEEDING AND SIGNIFICANT PROCEDURAL DIFFICULTY. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250450 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276
    1254609 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| O