BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT MINI CLSC 12IN RT ANGL Y EF

    MDR report key: 23136560 · Received September 24, 2025

    Report

    Report Number
    MW5176512
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    September 19, 2025
    Report Date
    September 19, 2025
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6), LOT 250828-297; EXT MINI CLSC 12IN RT ANGL Y EF "THE PART OF THE EXTENSION THAT GOES INTO THE G PORT OF THE G-JET IS BREAKING OFF AND IT IS UNABLE TO BE REMOVED. WHEN THIS HAPPENS, THEY ARE UNABLE TO CLOSE THE PORT AND GASTRIC CONTENTS QUICKLY LEAK OUT. ULTIMATELY IT REQUIRES URGENT SURGICAL INTERVENTION TO REPLACE THE G-JET. DAD NOTES THAT HE WAS ABLE TO GET THE PIECE OUT ONE OF THE TIMES, BUT THE OTHER TWO TIMES REQUIRED PLACEMENT OF A NEW G-JET." ITEM DISCARDED BY MEDICAL PROVIDERS AT TIME OF INTERVENTION AND UNABLE TO RETURN. WRITER MANAGES PRODUCT COMPLAINT PLATFORM AND THIS IS THE 4TH COMPLAINT FOR THIS ITEM THIS YEAR. THIS IS THE FIRST TIME SIGNIFICANT MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE BUT RISK OF HARM AND BEING UNABLE TO REMOVE THE PIECES ONCE BROKEN WERE PRESENT IN 2 OF THE OTHER COMPLAINTS ENTERED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394082 EXT MINI CLSC 12IN RT ANGL Y EF TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. 250828-297

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Hospitalization