BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 23442250 · Received October 31, 2025

    Report

    Report Number
    3006630150-2025-09893
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 2, 2025
    Report Date
    November 26, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURVED CANNULA WAS RETURNED AND ANALYZED. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS BROKEN. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION MUST BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENTS OR PROBE. EXCESSIVE FORCE CAN RESULT IN PRODUCT ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTERCEPT PROCEDURE AND WHEN THE CURVED CANNULA WAS REMOVED, THE DISTAL TIP WAS MISSING AND DAMAGED. IT WAS NOTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE DURING THE PROCEDURE AND A SMALL DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. HOWEVER, IT WAS UNKNOWN WHETHER THE DEVICE FRAGMENT WAS LEFT INSIDE OR OUTSIDE THE BONE. THE PHYSICIAN MOVED TO THE OTHER SIDE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE AND WHEN THE CURVED CANNULA WAS REMOVED, THE DISTAL TIP WAS MISSING AND DAMAGED. IT WAS NOTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE DURING THE PROCEDURE AND A SMALL DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. HOWEVER, IT WAS UNKNOWN WHETHER THE DEVICE FRAGMENT WAS LEFT INSIDE OR OUTSIDE THE BONE. THE PHYSICIAN MOVED TO THE OTHER SIDE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714371 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 37266940 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown