BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI, INC

    MDR report key: 19547016 · Received June 17, 2024

    Report

    Report Number
    19547016
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 6, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING ESOPHAGEAL DILATION, USING THE 18-20 EZDILATE FIXED WIRE DILATION BALLOON, BALLOON DID NOT DEFLATE PROPERLY AND WAS UNABLE TO BE REMOVED FROM THE SCOPE. SCOPE HAD TO BE REMOVED FROM PATIENT, AND TIP OF BALLOON HAD TO BE CUT IN ORDER TO REMOVE IT FROM THE SCOPE. MANUFACTURER RESPONSE FOR EZ DILATE FIXED WIRE ESOPHAGEAL 3 STAGE BALLOON CATHETER (18MM-20MM), EZ DILATE BALLOON (PER SITE REPORTER) SALES REPRESENTATIVE NOTIFIED. NO RESPONSE AS OF THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338859 GYRUS ACMI, INC DILATOR, ESOPHAGEAL KNQ GYRUS ACMI, INC. BD-400P-2080 381893

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female