BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUNODE SURGICAL GAMMA PROBE

    MDR report key: 20199440 · Received September 12, 2024

    Report

    Report Number
    20199440
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 21, 2024
    Manufacturer
    HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L.
    Product Code
    IZD
    UDI-DI
    15420045512856
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    OVER 60-YEAR-OLD FEMALE WITH RECENT HISTORY OF BREAST CANCER. PROCEDURE: LEFT BREAST REFLECTOR LOCALIZED LUMPECTOMY WITH SENTINEL LYMPH NODE BIOPSY, POSSIBLE AXILLARY DISSECTION. TRINODE PROBE WOULD NOT CALIBRATE WITH UNIT. ANOTHER PROBE USED SUCCESSFULLY. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR PROBE, UPTAKE, NUCLEAR, TRUNODE SURGICAL GAMMA PROBE (PER SITE REPORTER) WILL OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575137 TRUNODE SURGICAL GAMMA PROBE PROBE, UPTAKE, NUCLEAR IZD HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. 120-807605 24D26R 15420045512856

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female