BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 20765336 · Received November 22, 2024

    Report

    Report Number
    9610595-2024-23665
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    September 5, 2024
    Report Date
    March 28, 2025
    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 HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER: 2429304-2024-0000469. A3A: MALE WAS INADVERTENTLY SELECTED AND COULD NOT UNSELECTED. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (D9) AND AN UPDATE TO FIELDS (H3 AND H4). THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE REPORTED MALFUNCTION COULD NOT BE 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, THE DEVICE DID NOT HAVE ANY DEFECTS THAT COULD HAVE AFFECTED THE ANGULATION LOCK. THEREFORE, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. 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 - 0000469 THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION TO G3 DATE.

    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/PERFORATE. IT IS UNCLEAR IF THIS PATIENT UNDERWENT ANY TREATMENT. THE PHYSICIAN STATED THAT THE COLON WAS NOT INSUFFLATING DURING THE PROCEDURE, AND IT WAS UNCLEAR IF THE INSUFFLATOR MALFUNCTIONED OR IF THERE WAS A PROBLEM WITH THE SCOPE, OR IF IT WAS SOMETHING ELSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PENDING INFORMATION. THE CUSTOMER INDICATED 6 CASES OF PERFORATIONS OCCURRED. THUS, ADDITIONAL 4 CASES ARE REPORTED FOR PERFORATION. 2 PATIENTS HAD MICRO-PERFORATIONS IN THE COLON WERE TREATED. 4 PATIENTS HAD SURGERIES: REPAIR IN 1 PATIENT AND HEMICOLECTOMY IN 3 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852352 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H180AL 04953170339615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other ENDOSCOPIC CO2 REGULATION UNIT, MODEL-UCR, SN-UNK