BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVINA SMART SYSTEM

    MDR report key: 22870599 · Received August 22, 2025

    Report

    Report Number
    3009632672-2025-00026
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 22, 2025
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    KNT
    UDI-DI
    07333387028729
    PMA / PMN Number
    K190977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REPLACEMENT NAVINA SMART UNIT WAS SHIPPED TO THE USER AND CONFIRMED DELIVERED ON AUGUST 12. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED. THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER COULD NOT BE OBTAINED DESPITE FOUR FOLLOW-UP ATTEMPTS TO CONTACT THE USER. CONSEQUENTLY, PRODUCT EVALUATION AND BATCH RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    A USER OF THE NAVINA SMART ELECTRONIC CONTROL UNIT, USED IN CONJUNCTION WITH THE NAVINA SMART TRANSANAL IRRIGATION SYSTEM AND RECTAL BALLOON CATHETER, REPORTED RECURRING FUNCTIONAL ISSUES DURING USE. SPECIFICALLY, THE USER EXPERIENCED REPEATED OCCURRENCES OF ERROR CODES 501 AND 502 AT VARIOUS TIMES DURING IRRIGATION SESSIONS. ACCORDING TO THE USER, THE DEVICE BECOMES UNRESPONSIVE DURING THESE EPISODES AND CANNOT BE POWERED OFF MANUALLY. THE SYSTEM MUST BE LEFT TO FULLY DISCHARGE BEFORE IT CAN BE RESTARTED. THESE MALFUNCTIONS OCCUR WHILE THE RECTAL BALLOON IS INFLATED, PREVENTING NORMAL DEFLATION VIA THE SYSTEM. AS A RESULT, THE USER MUST MANUALLY DISCONNECT ALL TUBING IN ORDER TO REMOVE THE CATHETER FROM THE RECTUM. A REPLACEMENT NAVINA SMART UNIT WAS SHIPPED TO THE USER AND CONFIRMED DELIVERED ON AUGUST 12. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED. THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182603 NAVINA SMART SYSTEM NAVINA SMART CONTROL UNIT KNT WELLSPECT HEALTHCARE 69014 07333387028729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other