BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATEC 0914-20MR

    MDR report key: 25185570 · Received May 15, 2026

    Report

    Report Number
    1222780-2026-00283
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 15, 2026
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420045504899
    PMA / PMN Number
    K042290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CONDUCTED: THE REPORTED FAILURE OF AN ATEC DISPOSABLE DEVICE WAS INVESTIGATED BY POST-MARKET QUALITY ASSURANCE (PMQA) ON MAY 5, 2026. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED, AND THE OUTER CANNULA WAS FOUND DISENGAGED FROM THE HUB. FUNCTIONAL TESTING WAS SUBSEQUENTLY CONDUCTED. DURING THE TESTING PHASE, VIBRATION OF THE INNER CANNULA WAS OBSERVED. FOLLOWING FUNCTIONAL TESTING, AN INTERNAL INSPECTION WAS CARRIED OUT, WHICH IDENTIFIED A VISIBLE DEFLECTION OF THE INNER CANNULA. BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT FAILURE WAS CONFIRMED. THIS OBSERVATION WILL BE MONITORED AND TRENDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DEVICE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL FOLLOW WITH THE INFORMATION FROM THE DHR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE USER THAT DURING AN ATEC MRI GUIDED BREAST BIOPSY PROCEDURE ON (B)(6) 2026, WHILE ACQUIRING TISSUE SAMPLES FROM THE PATIENT, THE NEEDLE DETACHED FROM THE DEVICE HANDPIECE. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488824 ATEC 0914-20MR INSTRUMENT, BIOPSY KNW HOLOGIC, INC ATEC 0914-20MR E26A07RB 15420045504899

    Patients

    Seq Age Sex Outcome Treatment
    1