BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19393805 · Received May 24, 2024

    Report

    Report Number
    9610595-2024-10589
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    February 10, 2024
    Report Date
    June 27, 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, A RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT 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

    SINCE LITERATURE DESCRIBED GIF-Q260J, GIF-H290T AND THE DEVICE IS A EVIS LUCERA SERIES, GIF-H290T WAS SELECTED AS THE REPRESENTATIVE MODEL. THIS REPORT IS RELATED TO THE FOLLOWING LINKED 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 MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "THE MANAGEMENT OF DIRECT ORAL ANTICOAGULANTS FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A MULTICENTER OBSERVATIONAL STUDY" . LITERATURE SUMMARY BACKGROUND THERE IS A LACK OF REPORTS ON THE USE OF DIRECT ORAL ANTICOAGULANTS (DOACS) DURING COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). AIMS WE AIMED TO ASSESS WHETHER THE USE OF DOACS IS ASSOCIATED WITH A HIGHER INCIDENCE OF DELAYED BLEEDING (DB) AFTER ESD. METHODS A TOTAL OF 4175 COLORECTAL NEOPLASMS IN 3515 PATIENTS WERE DISSECTED AT OUR HOSPITALS DURING STUDY PERIOD. WE INCLUDED 3909 LESIONS IN THE FINAL ANALYSIS. THE LESIONS WERE DIVIDED INTO TWO GROUPS: THE NO-AT GROUP (3668 NEOPLASMS) AND THE DOAC GROUP (241 NEOPLASMS). WE ALSO COMPARED THE DOAC WITHDRAWAL GROUP (154 NEOPLASMS) AND THE DOAC CONTINUATION GROUP (87 NEOPLASMS). RESULTS AMONG THE 3909 LESIONS, DB OCCURRED IN A TOTAL OF 90 CASES (2.3%). THE RATE OF DB WAS 2.2% (82/3668), AND 3.3% (8/241), RESPECTIVELY. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATE OF DB BETWEEN THE NO-AT GROUP AND THE DOAC GROUP. IN THE DOAC GROUP, THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATE OF DB BETWEEN THE WITHDRAWAL GROUP (5.2%, 8/154) AND THE CONTINUATION GROUP (0%, 0/87). THE MULTIVARIABLE ANALYSIS IDENTIFIED THE LOCATION OF THE LESION IN THE RECTUM (ODDS RATIO [OR], 4.04; 95% CONFIDENCE INTERVAL [CI], 2.614¿6.242; P < 0.001) AND LESIONS = 30 MM IN DIAMETER (OR, 4.14; 95% CI, 2.349¿7.34; P < 0.001) AS INDEPENDENT RISK FACTORS FOR DB. CONCLUSIONS OUR FINDINGS SUGGEST THAT DOAC USE HAS NO SIGNIFICANT IMPORTANT ON THE RATE OF DB. PROSPECTIVE STUDIES ARE WARRANTED TO DETERMINE WHETHER TREATMENT WITH DOACS SHOULD BE INTERRUPTED PRIOR TO COLORECTAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS [NO-AT AGENT GROUP] DELAYED BLEEDING - 82 PATIENTS PERFORATION - 56 PATIENTS POST-ESD COAGULATION SYNDROME (PECS) - 66 PATIENTS [DIRECT ORAL ANTICOAGULANT (DOAC) GROUP] DELAYED BLEEDING - 8 PATIENTS PERFORATION - 5 PATIENTS POST-ESD COAGULATION SYNDROME (PECS) - 8 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677034 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H290T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention EVIS LUCERA COLONOVIDEOSCOPE, PCF-Q260JI| SINGLE USE ELECTROSURGICAL KNIFE, KD-650Q