BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 24184401 · Received January 26, 2026

    Report

    Report Number
    1423537-2026-00017
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 9, 2026
    Report Date
    February 17, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KNT
    UDI-DI
    10192253011562
    PMA / PMN Number
    K180622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE: PIF ADDITIONAL 510K NUMBER: K932295 AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. IN ADDITION, A GEMBA WALK WAS PERFORMED TO REVIEW THE MANUFACTURING PROCESS. ALL PROCESSES AND CONTROLS WERE REVIEWED AND VERIFIED TO BE FUNCTIONING CORRECTLY. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD TRIGGER THE REPORTED CONDITION. BASED ON ALL AVAILABLE INFORMATION, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PROBE HAD BURST AND WAS LEAKING. IT WAS REPLACED WITH A TEMPORARY PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241656 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 200, LLC 8884720247 2401208764 10192253011562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown