BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    MDR report key: 17071033 · Received June 6, 2023

    Report

    Report Number
    2429304-2023-00180
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    February 25, 2023
    Report Date
    June 13, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    GCJ
    UDI-DI
    04953170340710
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PROSPECTIVE RANDOMIZED COMPARISON OF THREE-DIMENSIONAL (3D) VERSUS CONVENTIONAL LAPAROSCOPY IN TOTAL COLECTOMY FOR ULCERATIVE COLITIS." OVERALL, 54 SUBJECTS WITH THE DIAGNOSIS OF UC ABOVE 18 YEARS OF AGE WHO UNDERWENT ELECTIVE TAC WITH END ILEOSTOMY BETWEEN JANUARY 2015 AND DECEMBER 2020 WERE ENROLLED IN THE STUDY. ONE SUBJECT IN THE 2D GROUP UNDERWENT CONVERSION TO OPEN SURGERY AND THEREFORE EXCLUDED FROM THE FINAL ANALYSIS (FIG. 1). A TOTAL OF 53 SUBJECTS (26 IN 2D GROUP, 27 IN 3D GROUP) WERE INCLUDED IN THE FINAL ANALYSIS, OF WHICH 56% WERE MALE WITH A MEAN AGE OF 40 (16.3) YEARS AND BODY MASS INDEX OF 23.5 (4.7) KG/M2. TWENTY-FIVE SUBJECTS UNDERWENT SINGLE PORT LAPAROSCOPIC SURGERY. AMONG THESE SUBJECTS, 12 OF THEM WERE IN THE 2D LAPAROSCOPY GROUP AND 13 OF THEM WERE IN THE 3D LAPAROSCOPY GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN TERMS OF DEMOGRAPHICS AND PERIOPERATIVE VARIABLES. THE OVERALL POST-OPERATIVE COMPLICATION RATES WERE COMPARABLE BETWEEN THE GROUPS (8 IN 3D VERSUS 8 IN 2D, P = 1). LENGTH OF HOSPITAL STAY WAS ALSO COMPARABLE BETWEEN THE GROUPS (3 DAYS IN 3D VERSUS 3 DAYS IN 2D, P = 0.91). ADVERSE EVENTS (AES)/ NUMBER OF PATIENTS POSTOPERATIVE COMPLICATIONS INCLUDED: 4 (14.8%) POSTOPERATIVE ILEUS, 1 WOUND DEHISCENCE (3.7%), 3 (11.1%) OTHERS IN 3D GROUP, 1 (3.9%) POSTOPERATIVE ILEUS, 2 (7.7%) DEEP VEIN THROMBOSIS, 2 (7.7%) SURGICAL SITE INFECTION, 2 (7.7%) OTHERS IN 2D GROUP. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS OBTAINED FROM THE AUTHOR. NO ADVERSE EVENT OCCURRED RELATED TO OUR DEVICE, AND THE AUTHOR ALSO CONFIRMED NO MALFUNCTION OCCURRED ON AN OLYMPUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746075 ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE FLEX 3D DEFLECTABLE VIDEOSCOPE GCJ AIZU OLYMPUS CO., LTD. LTF-190-10-3D 04953170340710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other