BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 22155434 · Received June 5, 2025

    Report

    Report Number
    3006630150-2025-03997
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 25, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURVED CANNULA WAS RETURNED AND A VISUAL INSPECTION CONFIRMED THAT THE CURVED CANNULA SHAFT TIP WAS BROKEN. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT 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 FAILURE. IT ALSO STATES THAT BREAKAGE, SLIPPAGE, MISUSE OR MISHANDLING OF INSTRUMENTS OR PROBE, SUCH AS ON SHARP EDGES, MAY CAUSE BURNS OR INJURY TO THE PATIENT OR OPERATIVE PERSONNEL IS A KNOWN RISK ASSOCIATED WITH THE USE OF THE INTRACEPT INTRAOSSEOUS NERVE ABLATION SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE TIP OF THE CURVED CANNULA PEEK BROKE OFF WHILE IT WAS BEING INSERTED INTO THE PATIENT. HARD BONE WAS ENCOUNTERED AND ABOUT ONE TO TWO LEVELS WERE COMPLETED PRIOR TO THE ISSUE OCCURRING. THE BROKEN DEVICE FRAGMENT COULD NOT BE FOUND ANYWHERE ON THE CURVED CANNULA AND IT WAS DETERMINED THAT THE BROKEN FRAGMENT WAS LEFT INSIDE THE PATIENT. IT COULD NOT BE CONFIRMED WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS SCHEDULED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE TIP OF THE CURVED CANNULA PEEK BROKE OFF WHILE IT WAS BEING INSERTED INTO THE PATIENT. HARD BONE WAS ENCOUNTERED AND ABOUT ONE TO TWO LEVELS WERE COMPLETED PRIOR TO THE ISSUE OCCURRING. THE BROKEN DEVICE FRAGMENT COULD NOT BE FOUND ANYWHERE ON THE CURVED CANNULA AND IT WAS DETERMINED THAT THE BROKEN FRAGMENT WAS LEFT INSIDE THE PATIENT. IT COULD NOT BE CONFIRMED WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618522 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 36334688 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female