BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 23640765 · Received November 24, 2025

    Report

    Report Number
    3006630150-2025-10780
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 30, 2025
    Report Date
    January 2, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURVED CANNULA, BEVEL STYLET, AND J-STYLET WERE RETURNED AND ANALYZED. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS SHEARED. THE BEVEL STYLET LATCH AND THE HANDLE WERE BROKEN. THE J-STYLET WAS TESTED WITH A KNOWN GOOD CURVED CANNULA AND A KNOWN GOOD INTRODUCER CANNULA. THE RESULTS SHOWED THAT THE J-STYLET LACKS ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE THAT THE PHYSICIAN ENCOUNTERED HARD BONE AND WHILE MALLEATING THE BEVEL STYLET AND INTRODUCER CANNULA, PART OF THE BLUE PLASTIC BROKE OFF THE TOP OF THE BEVEL STYLET. THE BROKEN PIECE WAS NOT INSIDE THE PATIENT. THE PHYSICIAN SWITCHED TO A DIAMOND STYLET AND WHEN THE CURVED CANNULA ASSEMBLY WAS REMOVED, HE NOTICED THAT PART OF THE PEEK BROKE OFF THE DISTAL END. IT IS LIKELY THAT SOME OF THE PEEK WAS LEFT BEHIND INSIDE THE PATIENT. SINCE NO DEVICE FRAGMENTS WERE VISIBLE ON THE X-RAY, IT COULD NOT BE CONFIRMED WHETHER THERE WERE DEVICE FRAGMENTS CONTAINED INSIDE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS USUAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERCEPT PROCEDURE THAT THE PHYSICIAN ENCOUNTERED HARD BONE AND WHILE INTERCEPT THE BEVEL STYLET AND INTRODUCER CANNULA, PART OF THE BLUE PLASTIC BROKE OFF THE TOP OF THE BEVEL STYLET. THE BROKEN PIECE WAS NOT INSIDE THE PATIENT. THE PHYSICIAN SWITCHED TO A DIAMOND STYLET AND WHEN THE CURVED CANNULA ASSEMBLY WAS REMOVED, HE NOTICED THAT PART OF THE PEEK BROKE OFF THE DISTAL END. IT IS LIKELY THAT SOME OF THE PEEK WAS LEFT BEHIND INSIDE THE PATIENT. SINCE NO DEVICE FRAGMENTS WERE VISIBLE ON THE X-RAY, IT COULD NOT BE CONFIRMED WHETHER THERE WERE DEVICE FRAGMENTS CONTAINED INSIDE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441756 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 37143683 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown