BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT

    MDR report key: 23625010 · Received November 21, 2025

    Report

    Report Number
    3006630150-2025-10701
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 24, 2025
    Report Date
    November 21, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006301
    PMA / PMN Number
    K222281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING AN INTRACEPT PROCEDURE, THE PHYSICIAN STATED THAT WHILE INITIATING ACCESS THROUGH THE SKIN WITH THE INTRODUCER CANNULA, THE INSTRUMENT SLIPPED LATERAL AND MAY HAVE PUNCTURED ABDOMINALLY. THE PATIENT EXPERIENCED ABDOMINAL PAIN IN THE POST ANESTHESIA CARE UNIT (PACU). THE PATIENT WAS LATER TRANSFERRED TO THE EMERGENCY ROOM (ER) AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED. THE CT SCAN SHOWED A LOWER GASTRIC BLEED. A BLOOD TRANSFUSION WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117922 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0045 37222391 00852454006301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R