BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUNODE SURGICAL GAMMA PROBE

    MDR report key: 22977081 · Received September 5, 2025

    Report

    Report Number
    22977081
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 18, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    IZD
    UDI-DI
    15420045512856
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DISPOSABLE TRUNODE HANDPIECE REF:120-807605 NOT WORKING. HANDPIECE TURNING ON AND TALKING TO TABLET BUT NOT PICKING UP NUCLEAR MEDICINE OVER PATIENT. TRIED NEW TABLET BUT HAD TO CHANGE OUT HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266265 TRUNODE SURGICAL GAMMA PROBE PROBE, UPTAKE, NUCLEAR IZD HOLOGIC, INC. 120-807605 25A23RC 15420045512856

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female