BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREVERA BREAST BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY

    MDR report key: 15936248 · Received December 7, 2022

    Report

    Report Number
    1222780-2022-00386
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 7, 2022
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420035507517
    PMA / PMN Number
    K163052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21. CFR PART 803. THE SUBMISSION IS BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONFIRMATION OF DEVICE MALFUNCTION INVOLVING THE HOLOGIC PRODUCTS IN THE EVENT DESCRIBED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. :THE FIELD ENGINEER PERFORMED THE DRIVER EVALUATION CHECKLIST: PASS. TURNED OFF THE FIREWALL PER TECH SUPPORT. RELOADED OCB AND CSL SOFTWARE. PERFORMED TRANSFER TO NODE PROCEDURE TO RESTORE DEFAULT NODE SETTINGS. PERFORMED NEW GAIN CALIBRATION. THE DRIVER WAS IN AN ARMED STATE. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A BREVERA PROCEDURE WAS PERFORMED, BUT THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE DUE TO AN ERROR IN THE SYSTEM WHILE THE NEEDLE WAS INSIDE THE BREAST OF THE PATIENT. THE PATIENT WAS RESCHEDULED FOR A NEW PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450649 BREVERA BREAST BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY BIOPSY SYSTEM KNW HOLOGIC, INC BREV100 15420035507517

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other