BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATEC 1212-20

    MDR report key: 25085946 · Received May 5, 2026

    Report

    Report Number
    1222780-2026-00201
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 5, 2026
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420045504912
    PMA / PMN Number
    K042290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE USER THAT DURING AN ATEC BREAST BIOPSY DEVICE PROCEDURE ON (B)(6), 2026, "NEEDLE WAS DIFFICULT TO GET INTO THE BUSHING AT START OF PROCEDURE, HAD TO USE 9G BUSHINGS INSTEAD. PROCEDURE WAS SUCCESSFUL BUT WHEN REMOVING THE NEEDLE, THEY NOTICED IT WAS SLIGHTLY DENTED/FLATTENED NEAR THE TIP, WHICH WOULD HAVE AFFECTED IT FITTING THROUGH THE 12G BUSHINGS." IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6), 2026. IT IS REPORTED THAT THE USER SITE HAS NOT KEPT THE DEVICE AFTER THE PROCEDURE; HOWEVER, ONE IMAGE WAS PROVIDED IN WHICH A SMALL DENT AT THE BASE BELOW THE APERTURE IS OBSERVED. IT IS REPORTED THAT WHEN USING THE ATEC BIOPSY DEVICE, THE USER SITE UTILIZES A GE UNIT, AND METAL BUSHING FROM GE AS THE NEEDLE GUIDE. IT IS REPORTED THAT THE NEEDLE WAS NOT FITTING WITHIN THE BUSHING, SO THE USER CHOSE THE LARGER 9G BUSHING TO CONTINUE WITH THE PROCEDURE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155667 ATEC 1212-20 INSTRUMENT, BIOPSY KNW HOLOGIC, INC ATEC 1212-20 E25J29RN 15420045504912

    Patients

    Seq Age Sex Outcome Treatment
    1