BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 18215117 · Received November 28, 2023

    Report

    Report Number
    9610595-2023-18073
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    October 18, 2023
    Report Date
    December 19, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 HEALTH EFFECT CLINICAL CODE TERM: POST-POLYPECTOMY COAGULATION SYNDROME. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 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. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO B5. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE LITERATURE ARTICLE TITLED, "EFFECT OF REAL-TIME COMPUTER-AIDED POLYP DETECTION SYSTEM (ENDO-AID) ON ADENOMA DETECTION IN ENDOSCOPISTS-IN-TRAINING: A RANDOMIZED TRIAL." BACKGROUND. THE EFFECT OF COMPUTER-AIDED POLYP DETECTION (CADE) ON ADENOMA DETECTION RATE (ADR) AMONG ENDOSCOPISTS-IN-TRAINING REMAINS UNKNOWN. METHODS. WE PERFORMED A SINGLE-BLIND, PARALLEL-GROUP, RANDOMIZED CONTROLLED TRIAL IN HONG KONG BETWEEN APRIL 2021 AND JULY 2022 (NCT04838951). ELIGIBLE SUBJECTS UNDERGOING SCREENING/SURVEILLANCE/DIAGNOSTIC COLONOSCOPIES WERE RANDOMIZED 1:1 TO RECEIVE COLONOSCOPIES WITH CADE (ENDO-AID(OIP-1), OLYMPUS CO., JAPAN) OR NOT (CONTROL) DURING WITHDRAWAL. PROCEDURES WERE PERFORMED BY ENDOSCOPISTS-IN-TRAINING WITH <500 PROCEDURES AND <3 YEARS' EXPERIENCE. RANDOMIZATION WAS STRATIFIED BY PATIENT AGE, SEX, AND ENDOSCOPIST EXPERIENCE (BEGINNER VS INTERMEDIATE-LEVEL, <200 VS 200-500 PROCEDURES). IMAGE ENHANCEMENT AND DISTAL ATTACHMENT DEVICES WERE DISALLOWED. SUBJECTS WITH INCOMPLETE COLONOSCOPIES OR INADEQUATE BOWEL PREPARATION WERE EXCLUDED. TREATMENT ALLOCATION WAS BLINDED TO OUTCOME ASSESSORS. THE PRIMARY OUTCOME WAS ADR. SECONDARY OUTCOMES WERE ADR FOR DIFFERENT ADENOMA SIZES AND LOCATIONS, MEAN NUMBER OF ADENOMAS, AND NON-NEOPLASTIC RESECTION RATE. RESULTS. 386 AND 380 SUBJECTS WERE RANDOMIZED TO CADE AND CONTROL GROUPS, RESPECTIVELY. THE OVERALL ADR WAS SIGNIFICANTLY HIGHER IN CADE THAN CONTROL GROUP (57.5% VS 44.5%, ADJUSTED RELATIVE RISK 1.41, 95%CI 1.17-1.72, P<0.001). THE ADRS FOR <5MM (40.4% VS 25.0%) AND 5-10MM ADENOMAS (36.8% VS 29.2%) WERE HIGHER IN CADE GROUP. THE ADRS WERE HIGHER IN CADE GROUP IN BOTH RIGHT (42.0% VS 30.8%) AND LEFT COLON (34.5% VS 27.6%), BUT THERE WAS NO SIGNIFICANT DIFFERENCE IN ADVANCED ADR. THE ADRS WERE HIGHER IN CADE GROUP AMONG BEGINNERS (60.0% VS 41.9%) AND INTERMEDIATE-LEVEL ENDOSCOPISTS (56.5% VS 45.5%). MEAN NUMBER OF ADENOMAS (1.48 VS 0.86) AND NON-NEOPLASTIC RESECTION RATE WERE HIGHER IN CADE GROUP (52.1% VS 35.0%). ADVERSE EVENT/NUMBER OF PATIENTS 1. POST-POLYPECTOMY COAGULATION SYNDROME (1 PATIENT). 2. DELAYED POST-POLYPECTOMY BLEEDING (2 PATIENTS). CONCLUSIONS. AMONG ENDOSCOPISTS-IN-TRAINING, THE USE OF CADE DURING COLONOSCOPIES WAS ASSOCIATED WITH INCREASED OVERALL ADR. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) - COLONOVIDEOSCOPE USED IN THE PROCEDURES. (B)(6) - COLONOVIDEOSCOPE USED IN THE PROCEDURES. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE LITERATURE. ALSO, AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545095 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ290L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CV-1500