BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME DUAL CORE

    MDR report key: 20560754 · Received October 28, 2024

    Report

    Report Number
    MW5161811
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 22, 2024
    Manufacturer
    IZI MEDICAL PRODUCTS LLC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MAMMOTOME BIOPSY DEVICE 16G WAS STICKING AND DIFFICULT TO ACTIVATE. A NEW MAMMOTOME BIOPSY DEVICE WAS USED AND THE PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982957 MAMMOTOME DUAL CORE INSTRUMENT, BIOPSY KNW IZI MEDICAL PRODUCTS LLC MCNX1610 FP241261

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female