BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EZDILATE

    MDR report key: 20225399 · Received September 16, 2024

    Report

    Report Number
    20225399
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    May 13, 2024
    Report Date
    May 24, 2024
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    KNQ
    UDI-DI
    00821925033184
    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 ESOPHAGEAL BALLOON DID NOT COMPLETELY DEFLATE WITH EQUIPMENT USED FOR THIS, NEEDED TO MANUALLY DEFLATE WITH A SYRINGE. DILATOR WOULD NOT LOCK, AND BALLOON WOULD NOT STAY DILATED TO MM SETTING, YOU HAD TO CONTINUOUSLY ADD TO BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441191 OLYMPUS EZDILATE DILATOR, ESOPHAGEAL KNQ GYRUS ACMI, LLC BD-400P-1380 395313 00821925033184

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male