BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOUGIECAP

    MDR report key: 24150107 · Received January 22, 2026

    Report

    Report Number
    24150107
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 6, 2026
    Manufacturer
    OVESCO ENDOSCOPY USA INC.
    Product Code
    KNQ
    UDI-DI
    04260206311485
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BOUGIE CAP WAS PLACED ON THE SCOPE AND FOLLOWING THE IFU [INSTRUCTIONS FOR USE] PLACING THE PROVIDED ADHESIVE TAPE. THIS TAPE IS CLEAR AND COMPLETELY COLORLESS, POSES DIFFICULTY SEEING POST PROCEDURE FOR REMOVAL. TAPE IS SINGLE USE AND MEANT FOR REMOVAL AFTER PATIENT USE. NOT INTENDED FOR REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214316 BOUGIECAP DILATOR, ESOPHAGEAL KNQ OVESCO ENDOSCOPY USA INC. 17/18 861065 04260206311485

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male