BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI, INC

    MDR report key: 18920749 · Received March 18, 2024

    Report

    Report Number
    18920749
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    November 28, 2023
    Report Date
    January 3, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KNQ
    UDI-DI
    00821925033269
    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

    DILATION BALLOON CATHETER SNAPPED INSIDE OF THE SCOPE WHILE PULLING THE CATHETER OUT OF THE SCOPE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956853 GYRUS ACMI, INC DILATOR, ESOPHAGEAL KNQ GYRUS ACMI, INC. BD-410X-1855 389462 00821925033269

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female