BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 24378621 · Received February 18, 2026

    Report

    Report Number
    9610595-2026-15781
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    May 17, 2023
    Report Date
    March 5, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: ESTABLISHMENT FULL NAME: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. THIS EVENT WAS INITIALLY REPORTED WITHOUT IDENTIFIED USE OR DEVICE PROBLEM. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION DURING INTAKE, THE INVESTIGATION FOUND NO DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE ARTICLE TITLED "TECHNICAL PERFORMANCE AND DIAGNOSTIC YIELD OF MOTORISED SPIRAL ENTEROSCOPY COMPARED WITH SINGLE-BALLOON ENTEROSCOPY IN SUSPECTED CROHN'S DISEASE: A RANDO MISED CONTROLLED, OPEN-LABEL STUDY (THE MOTOR-CD TRIAL)" . LITERATURE SUMMARY: OBJECTIVE: RECENT STUDIES HAVE SHOWN THAT MOTORIZED SPIRAL ENTEROSCOPY (MSE) ENABLES DEEPER AND TOTAL SMALL BOWEL EVALUATION COMPARED WITH SINGLE-BALLOON ENTEROSCOPY (SBE) IN SUSPECTED CROHN¿S DISEASE (CD) WHEN ANALYSED PER PROCEDURE. HOWEVER, NO RANDOMIZED CONTROLLED STUDY HAS COMPARED BIDIRECTIONAL MSE WITH BIDIRECTIONAL SBE IN SUSPECTED CD. DESIGN: PATIENTS WITH SUSPECTED CD REQUIRING SMALL BOWEL ENTEROSCOPY WERE RANDOMLY ASSIGNED TO EITHER SBE OR MSE BETWEEN MAY 2022 AND SEPTEMBER 2022 IN A HIGH VOLUME TERTIARY CENTRE. BIDIRECTIONAL ENTEROSCOPY WAS DONE IF INTENDED LESION COULD NOT BE REACHED ON UNIDIRECTIONAL STUDY. COMPARISON WAS MADE WITH REGARD TO TECHNICAL SUCCESS (ABILITY TO REACH LESION), DIAGNOSTIC YIELD, DEPTH OF MAXIMAL INSERTION (DMI), PROCEDURE TIME AND TOTAL ENTEROSCOPY RATES. DEPTH:TIME RATIO WAS CALCULATED TO AVOID CONFOUNDING FOR THE LOCATION OF LESION. RESULTS: AMONG 125 SUSPECTED PATIENTS WITH CD (28% FEMALE, 18¿65 YEARS, MEDIAN 41 YEARS), 62 AND 63 UNDERWENT MSE AND SBE, RESPECTIVELY. THE OVERALL TECHNICAL SUCCESS (98.4 %: MSE, 90.5 %: SBE; P=0.11), DIAGNOSTIC YIELD (95.2%: MSE; 87.3%: SBE, P=0.2) AND PROCEDURE TIME WERE NOT SIGNIFICANTLY DIFFERENT. HOWEVER, MSE APPEARED TO HAVE HIGHER TECHNICAL SUCCESS (96.8% VS 80.7%, P=0.08) IN DEEPER SMALL BOWEL (DISTAL JEJUNUM/PROXIMAL ILEUM) WITH HIGHER DMI, HIGHER DEPTH: TIME RATIO AND TOTAL ENTEROSCOPY RATES WHEN ATTEMPTED (77.8% VS 11.1%, P=0.0007). BOTH THE MODALITIES WERE SAFE ALTHOUGH MINOR ADVERSE EVENTS WERE MORE COMMON WITH MSE. CONCLUSION: MSE AND SBE HAVE COMPARABLE TECHNICAL SUCCESS AND DIAGNOSTIC YIELD FOR SMALL BOWEL EVALUATION IN SUSPECTED CD. MSE SCORES OVER SBE WITH REGARD TO DEEPER SMALL BOWEL EVALUATION WITH COMPLETE SMALL BOWEL COVERAGE AND HIGHER DEPTH OF INSERTION IN A SHORTER TIME. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. MUCOSAL INJURY AND SELF-LIMITING. INTRAPROCEDURAL BLEEDING (1 PATIENTS). POSTPROCEDURE PAIN REQUIRING HOSPITALIZATION FOR ONE DAY (1 PATIENTS). THERE WAS NO MENTION OF DEVICE MALFUNCTION IN THE ARTICLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION SUBMITTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439095 EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA AIZU OLYMPUS CO., LTD. SIF-Q260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization