BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELERO-12

    MDR report key: 19917067 · Received August 6, 2024

    Report

    Report Number
    19917067
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 5, 2024
    Report Date
    July 5, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    UDI-DI
    15420045504929
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HERE FOR A LEFT BREAST BIOPSY. RADIOLOGIST WAS ABLE TO OBTAIN TWO ADEQUATE TISSUE SAMPLES. HOWEVER, AFTER TAKING THE SECOND SAMPLE OUT OF THE DEVICE'S SAMPLING NOTCH, THE DEVICE WOULD NOT ALLOW TO BE RESET FOR ANOTHER SAMPLE. THEREFORE, ANOTHER DEVICE WAS OPENED, AND THE BIOPSY WAS THEN COMPLETED. DEVICE INFO: CELERO BREAST BIOPSY DEVICE BY HOLOGIC, INC. (12 GAUGE). LOT: E23E05RP. EXP: 5/4/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674680 CELERO-12 INSTRUMENT, BIOPSY KNW HOLOGIC, INC. CELERO-12 E23E05RP 15420045504929

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female