BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREVERA BREAST BIOPSY SYSTEM

    MDR report key: 20592129 · Received November 1, 2024

    Report

    Report Number
    1222780-2024-00411
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 1, 2024
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420045507760
    PMA / PMN Number
    K163052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 THAT DURING A BREVERA PROCEDURE ON OCTOBER 3RD WHILE THE NEEDLE WAS IN THE PATIENT, THE NEEDLE FAILED TO FIRE, AND THEY REPLACED ALL NEEDLES, BUT THE ISSUE PERSISTED THUS POINTING TO THE CONSOLE. A FIELD ENGINEER EXAMINED THE EQUIPMENT, AND IT WAS DETERMINED THAT THE LOGS INDICATED DRIVER ERRORS. IT WAS RECOMMENDED TO REPLACE THE DRIVER AND SOFTWARE. A NEW DRIVER WAS INSTALLED, AND UPDATED THE CSL, OCB AND NAND SOFTWARE. PRE ANT POST FIRE WAS CHECKED, AND THE SYSTEM WAS VERIFIED AND THE SYSTEM MEETS THE MANUFACTURER'S SPECIFICATIONS. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774203 BREVERA BREAST BIOPSY SYSTEM INSTRUMENT, BIOPSY KNW HOLOGIC, INC BREVDRV 15420045507760

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other