BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 19497405 · Received June 10, 2024

    Report

    Report Number
    19497405
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    April 3, 2024
    Report Date
    May 13, 2024
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: METAL SHAVING FOUND AFTER REMOVAL FROM PT. BACKGROUND: CLEANING A NEW ITEM FROM A NEW SURGERY. ASSESSMENT: WHEN CLEANING A J-STYLETTE AND CURVED CANNULA ASSEMBLY A METAL SHAVING WAS FOUND, NOTIFIED THE REP AND SURGEON, NO EVIDENCE TO ANY DAMAGE TO THE PATIENT OR OTHER EQUIPMENT. INSTRUMENT WAS BAGGED AND RETURNED TO COMPANY BY REP. MANUFACTURER RESPONSE FOR J-STYLETTE, (BRAND NOT PROVIDED) (PER SITE REPORTER) GIVEN TO REP IN REAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609363 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 732717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown