BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 20364240 · Received October 3, 2024

    Report

    Report Number
    9610595-2024-20046
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 5, 2024
    Report Date
    November 8, 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 DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE REPORTED ISSUE (LOCKED ANGULATION) WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 14 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) IN SECTION: ¿INSPECTION OF THE BENDING MECHANISMS¿ THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. B5 UPDATED ACCORDINGLY. ALSO, AN UPDATE HAS BEEN MADE TO H3. 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: 2429304-2024-0000433. THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL PROCEDURE (COLONOSCOPY WITH BIOPSIES) WAS NOT PROLONGED AND WAS COMPLETED USING THE SAME DEVICE. THE PATIENT¿S INJURY (COLON PERFORATION) WAS NOTED AFTER THE PROCEDURE. THE PATIENT UNDERWENT A RIGHT HEMICOLECTOMY THE SAME DAY TO TREAT THE PERFORATION.

    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. DUE TO THE PERFORATION, THE PATIENT HAD TO HAVE A RIGHT HEMICOLECTOMY. 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 MULTIPLE TIMES BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267548 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H180AL 04953170339615

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention ENDOSCOPIC CO2 REG. UNIT: SN(B)(6)