BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 20286059 · Received September 23, 2024

    Report

    Report Number
    9610595-2024-19021
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 6, 2024
    Report Date
    October 21, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170363672
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000414. 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 (LM) FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, A RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ADVERSE EVENT COULD NOT BE IDENTIFIED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) IN SECTION: PROHIBITION OF IMPROPER REPAIR AND MODIFICATION: "THIS INSTRUMENT DOES NOT CONTAIN ANY USER-SERVICEABLE PARTS. DO NOT DISASSEMBLE, MODIFY, OR ATTEMPT TO REPAIR IT; PATIENT OR OPERATOR INJURY AND/OR EQUIPMENT DAMAGE MAY RESULT." "EQUIPMENT THAT HAS BEEN DISASSEMBLED, REPAIRED, ALTERED, CHANGED, OR MODIFIED BY PERSONS OTHER THAN OLYMPUS¿ OWN AUTHORIZED SERVICE PERSONNEL IS EXCLUDED FROM OLYMPUS¿ LIMITED WARRANTY AND IS NOT WARRANTED BY OLYMPUS IN ANY MANNER.¿ THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO D8 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE A-RUBBER BROKE OFF TOWARDS THE TIP OF THE SCOPE AND THE BENDING SECTION PERFORATED THE PATIENT DURING AN UNSPECIFIED PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE THE SCOPE AND PATCH THE INJURY ON THE PATIENT. DESPITE MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION, NONE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502759 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190DL 04953170363672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention