BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 23519845 · Received November 11, 2025

    Report

    Report Number
    3006630150-2025-10244
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    June 9, 2025
    Report Date
    December 16, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006257
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT FIELD (B3): APPROXIMATED DATE BASED ON THE PRODUCT RETURN DATE.

    Additional Manufacturer Narrative · 0

    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. DATE OF EVENT FIELD (B3): APPROXIMATED DATE BASED ON THE PRODUCT RETURN DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CURVED CANNULA WAS RETURNED FOR AN UNKNOWN REASON. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS SHEARED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CURVED CANNULA WAS RETURNED FOR AN UNKNOWN REASON. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS SHEARED. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542046 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0075 741716 00852454006257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown