BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 22929344 · Received August 29, 2025

    Report

    Report Number
    3006630150-2025-07065
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 6, 2025
    Report Date
    October 17, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERCEPT CURVED CANNULA WAS RETURNED AND ANALYZED. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS BROKEN. THE BREAKAGE OF THE CURVED CANNULAS SHAFT TIP WAS LIKELY DUE TO USE OF EXCESSIVE FORCE DURING THE PROCEDURE. 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 THE PROBE. IT ALSO STATES THAT BREAKAGE, SLIPPAGE, MISUSE OR MISHANDLING OF INSTRUMENTS OR THE 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 PHYSICIAN MADE MULTIPLE ATTEMPTS TO TROUBLESHOOT HITTING THE TARGET BY REMOVING THE J-STYLET MULTIPLE TIMES TO INSERT THE PROBE. WHEN THE CURVED CANNULA WAS REMOVED, THE TIP OF THE PEEK WAS SHEARED OFF. IT COULD NOT BE CONFIRMED WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS SCHEDULED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERCEPT PROCEDURE, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO TROUBLESHOOT HITTING THE TARGET BY REMOVING THE J-STYLET MULTIPLE TIMES TO INSERT THE PROBE. WHEN THE CURVED CANNULA WAS REMOVED, THE TIP OF THE PEEK WAS SHEARED OFF. IT COULD NOT BE CONFIRMED WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS SCHEDULED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865535 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 36201850 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female