BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 16451901 · Received February 28, 2023

    Report

    Report Number
    16451901
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    November 15, 2022
    Report Date
    February 16, 2023
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE WORKING ON RIGHT SIDE, LEVEL S-1, APPROXIMATELY 1/4" OF THE PEEK RADIOLUCENT PLASTIC SHEATH, SHEARED OFF, IN PATIENT. SURGEON AWARE. UNABLE TO RETRIEVE OR VISUALIZE WITH FLUOROSCOPY. PROCEED WITH PROCEDURE PER MD. MANUFACTURER RESPONSE FOR PROBE, RADIOFREQUENCY LESION, RELIEVANT MEDSYSTEMS INTRACEPT ACCESS INSTRUMENTS (PER SITE REPORTER). VENDOR WAS PRESENT AT TIME OF SURGERY AND SURGEON MADE HIM AWARE. SURGEON: "WE HAVE ALSO DISCUSSED IT WITH THE DEVICE REPRESENTATIVE SO THAT THEIR COMPANY IS AWARE OF IT, AND HOPEFULLY THEY WILL CONTINUE TO IMPROVE THEIR TECHNOLOGY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657288 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. FG 0060

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA Male