BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19533394 · Received June 13, 2024

    Report

    Report Number
    9610595-2024-11982
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    March 18, 2024
    Report Date
    July 1, 2024
    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. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    A2: MEDIAN AGE 54 YEARS OLD THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). THE DEVICE WAS NOT RETURNED. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION FOR EARLY GASTRIC NEOPLASMS: A MULTICENTER CASE SERIES STUDY". LITERATURE SUMMARY SEVERAL CASES HAVE BEEN REPORTED THAT SUGGEST THE EFFICACY OF GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION (GI-EMR) FOR GASTRIC NEOPLASMS. HOWEVER, NO STUDY HAS EVALUATED TREATMENT OUTCOMES OF GI-EMR FOR GASTRIC NEOPLASMS. THIS STUDY AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF GI-EMR FOR EARLY GASTRIC NEOPLASMS. NINE PATIENTS (17 LESIONS) UNDERGOING GASTRIC GI-EMR WERE INCLUDED, WITH A MEDIAN LESION SIZE OF 10MM (INTERQUARTILE RANGE [IQR] 5¿13 MM). ALL LESIONS WERE PROTRUDING OR FLAT ELEVATED. THE MEDIAN PROCEDURE TIME WAS 3 MINUTES (IQR 2¿5) AND EN BLOC RESECTION WAS ACHIEVED IN ALL CASES. AMONG 15 NEOPLASTIC LESIONS, THE R0 RESECTION RATE WAS 86.7% (13/15 LESIONS). ADVERSE EVENTS INCLUDED IMMEDIATE BLEEDING REQUIRING HEMOSTASIS IN TWO CASES, WHICH WAS CONTROLLED ENDOSCOPICALLY. NO DELAYED BLEEDING OR PERFORATION OCCURRED. IN CONCLUSION, GI-EMR MAY BE A SAFE AND EFFECTIVE TREATMENT FOR EARLY, SMALL GASTRIC NEOPLASMS. HOWEVER, DUE TO THE SMALL SAMPLE IN THE PRESENT STUDY, FURTHER INVESTIGATION IS REQUIRED REGARDING THE INDICATION FOR THIS TECHNIQUE. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE: IMMEDIATE BLEEDING (2)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937212 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H290Z

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Required Intervention (D-201-11804)| GIF-Q260J| SD-400U-10