BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 24378991 · Received February 18, 2026

    Report

    Report Number
    9610595-2026-15800
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    November 10, 2023
    Report Date
    February 18, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED ¿SINGLE-BALLOON ENTEROSCOPY (SBE)¿: OLYMPUS SELECTED SIF-Q260 AS A REPRESENTATIVE PRODUCT. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿DEVICE-ASSISTED ENTEROSCOPY PERFORMANCE MEASURES IN THE UNITED KINGDOM: DEEP-UK QUALITY IMPROVEMENT PROJECT¿. BACKGROUND: DEVICE-ASSISTED ENTEROSCOPY (DAE) HAS BECOME A WELL-ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL FOR THE MANAGEMENT OF SMALL-BOWEL PATHOLOGY. WE AIMED TO EVALUATE THE PERFORMANCE MEASURES FOR DAE ACROSS THE UK AGAINST THE QUALITY BENCHMARKS PROPOSED BY THE EUROPEAN SOCIETY OF GASTROINTESTINAL ENDOSCOPY (ESGE). METHODS: WE RETROSPECTIVELY COLLECTED DATA ON PATIENT DEMOGRAPHICS AND DAE PERFORMANCE MEASURES FROM ELECTRONIC ENDOSCOPY RECORDS OF CONSECUTIVE PATIENTS WHO UNDERWENT DAE FOR DIAGNOSTIC AND THERAPEUTIC PURPOSES ACROSS 12 ENTEROSCOPY CENTERS IN THE UK BETWEEN JANUARY 2017 AND DECEMBER 2022. RESULTS: A TOTAL OF 2005 DAE PROCEDURES WERE PERFORMED IN 1663 PATIENTS (MEDIAN AGE 60 YEARS; 53% MEN). ALMOST ALL PROCEDURES (98.1%) WERE PERFORMED FOR APPROPRIATE INDICATIONS. DOUBLE-BALLOON ENTEROSCOPY WAS USED FOR MOST PROCEDURES (82.0%), FOLLOWED BY SINGLE-BALLOON ENTEROSCOPY (17.2%) AND SPIRAL ENTEROSCOPY (0.7%). THE ESTIMATED DEPTH OF INSERTION WAS DOCUMENTED IN 73.4% OF PROCEDURES. THE OVERALL DIAGNOSTIC YIELD WAS 70.0%. THERAPEUTIC INTERVENTIONS WERE PERFORMED IN 42.6% OF PROCEDURES, WITH A SUCCESS RATE OF 96.6%. OVERALL, 78.0% OF DETECTED LESIONS WERE MARKED WITH A TATTOO. PATIENT COMFORT WAS SIGNIFICANTLY BETTER WITH THE USE OF DEEP SEDATION COMPARED WITH CONSCIOUS SEDATION (99.7% VS. 68.5%; P<0.001). MAJOR ADVERSE EVENTS OCCURRED IN ONLY 0.6% OF PROCEDURES. CONCLUSIONS: PERFORMANCE MEASURES FOR DAE IN THE UK MEET THE ESGE QUALITY BENCHMARKS, WITH HIGH DIAGNOSTIC AND THERAPEUTIC YIELDS, AND A LOW INCIDENCE OF MAJOR ADVERSE EVENTS. HOWEVER, THERE IS ROOM FOR IMPROVEMENT IN OPTIMIZING SEDATION PRACTICES, STANDARDIZING THE DEPTH OF INSERTION DOCUMENTATION, AND ADOPTING MARKING TECHNIQUES TO AID IN THE FOLLOW-UP OF DETECTED LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. EVENT1: ADVERSE EVENTS (MINOR) (DBE OR SBE) (32 CASES). THE FOLLOWING EVENTS ARE INCLUDED. ··MAINLY SELF-LIMITED OXYGEN DESATURATION. ··BRADYCARDIA AND HYPOTENSION SECONDARY TO SEDATION. EVENT2: ADVERSE EVENTS (MAJOR) (DBE OR SBE) (12 CASES). THE FOLLOWING EVENTS ARE INCLUDED. ··PERFORATION (5 CASES) (THE ¿RESULTS¿ STATED 6 CASES, BUT ONE OF THESE OCCURRED IN MSE AND THEREFORE EXCLUDED FROM THIS EVENT.) ··PNEUMONIA REQUIRING HOSPITALIZATION (3 CASES). ··POST-POLYPECTOMY BLEEDING (2 CASES). ··SEVERE PANCREATITIS (1 CASE). ··UNSTABLE CARDIAC ARRHYTHMIA (1 CASE). THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546901 EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA AIZU OLYMPUS CO., LTD. SIF-Q260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown