BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 25310755 · Received May 27, 2026

    Report

    Report Number
    3006897778-2026-00015
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 27, 2026
    Manufacturer
    CROSPON LTD
    Product Code
    FFX
    UDI-DI
    10884521808096
    PMA / PMN Number
    K160725
    Removal / Correction Number
    282497-05-20-2026-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: EF-322N, ENDO CATHETER EF-322N 16CM NASAL TIP (LOT#25C1042JZ) UPON EVALUATION, ANY CATHETER UTILIZED ON THE EF-100 SYSTEM FOLLOWING JANUARY 1, 2026 WILL BE INCORRECTLY FLAGGED AS EXPIRED DUE TO THE SYSTEM¿S 24-HOUR USAGE LIMIT, RENDERING THE CATHETER UNAVAILABLE FOR CLINICAL PROCEDURES. THE REAL TIME CLOCK WAS SET UP WITH A BASE YEAR OF 2010 AND WILL NOT SUPPORT CATHETERS AFTER 2025. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER DISPLAYED AN ERROR MESSAGE STATING ¿REACHED MAXIMUM NUMBER OF USES¿ WHEN CONNECTED TO PERFORM PRE-USE CHECK. THE CATHETER WAS DISCONNECTED AND RECONNECTED, AND THE SYSTEM WAS RESTARTED; HOWEVER, THE CATHETER CONTINUED TO FAIL WITH THE SAME ERROR. THE PRE-USE CHECK WAS ATTEMPTED THREE TIMES WITH THE SAME FAILURE. THE CATHETER WAS THEN SWITCHED TO A NEW CATHETER, WHICH PASSED THE PRE-USE CHECK. THERE WAS NO PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380058 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LTD RFG-EF100 10884521808096

    Patients

    Seq Age Sex Outcome Treatment
    1