BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREVERA BREAST BIOPSY SYSTEM

    MDR report key: 15385005 · Received September 8, 2022

    Report

    Report Number
    1222780-2022-00241
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 8, 2022
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420045507517
    PMA / PMN Number
    K163052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. FIELD ENGINEER WAS ABLE TO EXAMINE THE CONSOLE AND FOUND THE FOLLOWING ; ISSUES WITH SOFTWARE GETTING STUCK DURING LAUNCHING. FOUND ISSUES WITH TRAY ALIGNMENT AND INTERNAL MECHANISM. FOUND ARTIFACTS ON THE IMAGES AND RUN TESTING. RAN ALL APPLICABLE CALIBRATIONS. VERIFIED THE REPAIR FIXED THE REPORTED ISSUE. SYSTEM MEETS MANUFACTURERS SPECIFICATIONS AFTER THE WORK ON IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2022 THE BREVERA WAS NOT TAKING TISSUE SAMPLES DURING PROCEDURE. SEEING ERROR CSL 16:16. PATIENT DEVELOPED HEMATOMA FROM EXTENDED PROBE INSERTION TIME. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235911 BREVERA BREAST BIOPSY SYSTEM INSTRUMENT, BIOPSY KNW HOLOGIC, INC BREV100 15420045507517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other