BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS COLONOSCOPE

    MDR report key: 25175675 · Received May 14, 2026

    Report

    Report Number
    MW5188265
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 12, 2026
    Manufacturer
    OLYMPUS AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SCHEDULED COLONOSCOPY, THE MD WAS HAVING DIFFICULTY ADVANCING THE COLONOSCOPE. AFTER A FEW MINUTES OF ATTEMPTING TO ADVANCE THE SCOPE, THE PROVIDER REMOVED THE SCOPE TO REVEAL THAT THE SCOPE HAD BROKEN AND HAD EXPOSED WIRES. THIS RESULTED IN TISSUE DAMAGE AND PERFORATION OF SIGMOID, REQUIRING PATIENT TO UNDERGO SIGMOID COLECTOMY WITH COLOSTOMY CREATION. PRE-OP DIAGNOSIS OF SMALL DUODENAL ULCER, COLONOSCOPY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247392 OLYMPUS COLONOSCOPE COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF OLYMPUS AIZU OLYMPUS CO., LTD. CF-HQ190L

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| R