BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIVA 0913-12

    MDR report key: 18459777 · Received January 5, 2024

    Report

    Report Number
    1222780-2024-00009
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 7, 2023
    Report Date
    January 5, 2024
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    PMA / PMN Number
    K180233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. A FIELD ENGINEER EXAMINED THE EQUIPMENT CONSOLE, AND IT WAS DETERMINED THAT THE USER HAD MADE AN ERROR WHILE SELECTING THE SIZE OF THE NEEDLE, THEY SELECTED A NEEDLE MUCH SHORTER IN THE SOFTWARE THAN THE ONE INSTALLED WHICH RESULTED IN THE ERROR IN THE SAFETY MARGIN AND WHY THE NEEDLE WENT THROUGH THE BREAST. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. 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 DURING AN EVIVA PROCEDURE ON (B)(6) 2023, DURING THE TISSUE ACQUISITION THE POST FIRE POSITION WAS FIRED WITH SUCH FORCE THAT IT PASSED THE BIOPSY PARAMETERS SET AND THROUGH THE PATIENT´S BREAST. A THIRD NEEDLE WAS USED TO COMPLETE THE PROCEDURE. A FIELD ENGINEER EXAMINED THE EQUIPMENT, AND IT WAS DETERMINED THAT THE USER HAD MADE AN ERROR WHILE SELECTING THE SIZE OF THE NEEDLE, THEY SELECTED A NEEDLE MUCH SHORTER IN THE SOFTWARE THAN THE ONE INSTALLED WHICH RESULTED IN THE ERROR IN THE SAFETY MARGIN AND WHY THE NEEDLE WENT THROUGH THE BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687742 EVIVA 0913-12 INSTRUMENT, BIOPSY KNW HOLOGIC, INC EVIVA_0913-12 E23G05R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other