BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 25310743 · Received May 27, 2026

    Report

    Report Number
    3006897778-2026-00014
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 27, 2026
    Manufacturer
    CROSPON LTD
    Product Code
    FFX
    UDI-DI
    05391530810050
    PMA / PMN Number
    K160725
    Removal / Correction Number
    282497-05-20-2026-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON EVALUATION, ANY CATHETER UTILIZED ON THE EF-100 SYSTEM FOLLOWING (B)(6) 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. D10 CONCOMITANT PRODUCT: EF-325N, ENDO CATHETER EF-325N 8 CM NASAL TIP (LOT# 24D1427JZ). 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER FAILED THE PRE-USE CHECK THRICE. THE CUSTOMER DISCONNECTED THE CATHETER AND RESTARTED THE SYSTEM, AND THE CATHETER CONTINUED TO FAIL THE PRE-USE CHECK. A NEW CATHETER WAS USED AND IT PASSED THE PRE-USE CHECK. THERE WAS NO PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352923 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LTD EF-100 05391530810050

    Patients

    Seq Age Sex Outcome Treatment
    1