BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17807598 · Received September 25, 2023

    Report

    Report Number
    9610595-2023-13944
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    July 20, 2023
    Report Date
    October 12, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. IN ADDITION, THE MALFUNCTION OF THE DEVICE HAS NOT BEEN REPORTED, AND FROM CLINICAL/MEDICAL EVALUATION AND RISK ASSESSMENT, IT IS POSSIBLE THAT THE REPORTED EVENT IS AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A PROCEDURE USING THE SUBJECT DEVICE. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED AS REFLECTED ON B5.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE LITERATURE IS ATTACHED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED FURTHER INFORMATION INDICATING THAT THE AUTHOR HAS CONFIRMED THAT THE ADVERSE EVENTS DESCRIBED IN THE LITERATURE WERE NOT FROM THE OLYMPUS DEVICES AND THAT THERE WAS NO MALFUNCTION OF ANY KIND WITH THE OLYMPUS DEVICES.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "TECHNIQUE DESCRIPTION GEL IMMERSION EMR (UNDER-GEL EMR) FOR DUODENAL TUMORS - A NEW ENDOSCOPIC RESECTION METHOD FOR SUPERFICIAL NON-PAPILLARY DUODENAL TUMORS." LITERATURE SUMMARY: ALTHOUGH THE IMPORTANCE OF ENDOSCOPIC RESECTION OF DUODENAL TUMORS IS BECOMING INCREASINGLY RECOGNIZED, EMR IS ASSOCIATED WITH A CERTAIN FREQUENCY OF BLEEDING, PERFORATION, AND OTHER COMPLICATIONS. IN RECENT YEARS, THE USEFULNESS OF UNDERWATER EMR, IN WHICH THE LESION IS FLOODED WITHOUT LOCAL INJECTION AND RESECTED BY SNARING, HAS BEEN INCREASINGLY REPORTED. HOWEVER, SOME LESIONS ARE DIFFICULT TO COLLECT WATER IN CERTAIN AREAS, AND VISIBILITY MAY BE REDUCED UNDER WATER DUE TO RESIDUALS. THEREFORE, THERE HAVE BEEN A NUMBER OF REPORTS ON GEL IMMERSION EMR (UNDER-GEL EMR), IN WHICH THE LESION IS IMMERSED USING A GEL TO SECURE THE FIELD OF VIEW DURING ENDOSCOPIC HEMOSTASIS, INSTEAD OF WATER. THIS PAPER DESCRIBES THE METHOD AND PROSPECTS OF THIS TECHNIQUE. PATIENTS WERE DIAGNOSED WITH ADENOMAS BY PREOPERATIVE ENDOSCOPIC BIOPSY OR BY ENDOSCOPIC DIAGNOSIS. FOURTEEN PATIENTS WITH 14 LESIONS WERE TREATED WITH UEMR AND 15 PATIENTS WITH 17 LESIONS WERE TREATED WITH GIEMR. NO PERFORATION OR DELAYED BLEEDING WAS OBSERVED IN EITHER GROUP. INTRAOPERATIVE BLEEDING OCCURRED IN ONE CASE IN THE GIEMR GROUP AND ONE CASE IN THE UEMR GROUP, BUT BOTH CASES COULD BE STOPPED WITH A CLIP. NO OTHER SERIOUS COMPLICATIONS WERE OBSERVED IN EITHER GROUP. CONCLUSION GIEMR IS SAFE AND USEFUL FOR SNADETS, AND THE PROCEDURE TIME IS REDUCED COMPARED TO UEMR. GEL IMMERSION MAY ALSO BE USEFUL IN EP FOR PAPILLARY TUMORS, INCLUDING POSTOPERATIVE RECONSTRUCTED INTESTINE. HOWEVER, FURTHER CASE SERIES ARE NEEDED BECAUSE THIS STUDY WAS PERFORMED IN A SMALL NUMBER OF PATIENTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE BLEEDING - 2 PATIENT. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6). THIS MEDWATCH REPORT IS FOR (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835264 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention