BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC TRUNODE

    MDR report key: 12016675 · Received June 16, 2021

    Report

    Report Number
    MW5101950
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 15, 2021
    Manufacturer
    FAXITRON BIOPTIC, LLC / HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L.
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SENTINEL LYMPH NODE BIOPSY, THE GAMMA PROBE SEEMED TO BE ACTING OVERLY SENSITIVE AND ERRATIC. AFTER DISSECTION OF THE SPECIMEN, THE PROBE WOULD NO LONGER REGISTER IT. ANOTHER PROBE WAS OPENED WHEN TESTED ON THE TISSUE, IT APPEARED TO HAVE ACCURATE READINGS. THE CASE CONTINUED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902808 HOLOGIC TRUNODE PROBE, UPTAKE, NUCLEAR IZD FAXITRON BIOPTIC, LLC / HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. TRUNODE S-10 090120

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR