BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVERA BREAST BIOPSY SYSTEM

    MDR report key: 16272731 · Received January 30, 2023

    Report

    Report Number
    MW5114581
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 26, 2023
    Report Date
    January 27, 2023
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN THE BIOPSY SULLE, THE LEFT BREAST WAS POSITIONED FROM A CC APPROACH. THE SKIN WAS PREPPED AND DRAPED USING THE STANDARD ASEPTIC TECHNIQUE. LOCAL ANESTHESIA WAS ADMINISTERED. A TINY SKIN NICK WAS MADE WITH A SCALPEL. A 9 GAUGE BREVERA BIOPSY DEVICE WAS THEN POSITIONED. PREFIRE IMAGES WERE OBTAINED. HOWEVER, THE BIOPSY DEVICE WAS UNABLE TO FIRE AND BIOPSY SAMPLING COULD NOT BE PERFORMED. AN ERROR MESSAGE WAS PRESENT ON THE BIOPSY COMPUTER CONSOLE, INDICATING THAT THERE IS A TECHNICAL ISSUE WITH THE BIOPSY EQUIPMENT. THE NEEDLE WAS REMOVED AND THE COMPUTER WAS RESET. RE-TARGETING WAS PERFORMED AND A SECOND ATTEMPT WAS MADE TO PERFORM THE BIOPSY. THE SAME SKIN NICK WAS UTILIZED. THE NEEDLE WAS POSITIONED. TARGETING WAS PERFORMED USING DBT AND STEREOTACTIC GUIDANCE. ONCE AGAIN, HOWEVER, THE BIOPSY NEEDLE MALFUNCTIONED. THE NEEDLE WAS ABLE TO FIRE. HOWEVER, ONLY A SINGLE TISSUE CORE COULD BE OBTAINED, WHICH BECAME LODGED INSIDE THE BIOPSY DEVICE AND COULD NOT BE EXTRACTED AND SENT TO PATHOLOGY FOR HISTOLOGIC EVALUATION. NO ADD'L SAMPLES COULD BE OBTAINED AND THE PROCEDURE WAS CANCELED. THE PROCEDURE WILL BE RESCHEDULED ON A SUBSEQUENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384804 BREVERA BREAST BIOPSY SYSTEM INSTRUMENT, BIOPSY KNW HOLOGIC, INC. BREVDISP09 22G24RG

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other