BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 20733056 · Received November 20, 2024

    Report

    Report Number
    9610595-2024-40046
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 29, 2024
    Report Date
    April 30, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K100584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. UPDATED FIELDS: D8, H2, H6 AND H10. 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 COMPLAINT WAS CONFIRMED AN THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE NOT ESTABLISHED. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-01004-01.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-01004. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    DURING A DIAGNOSTIC COLONOSCOPY, WHILE THE PATIENT WAS UNDER SEDATION, THE SCOPE HAD LOW SUCTION, AND INSUFFLATION WAS POOR WHICH RESULTED IN A PROCEDURAL DELAY GREATER THAN OR EQUAL TO 30 MINUTES. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430813 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H180AL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown