BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK

    MDR report key: 9679771 · Received February 6, 2020

    Report

    Report Number
    3008492462-2020-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 4, 2020
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC
    Product Code
    NEU
    UDI-DI
    00841911101659
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAMMOMARK BIOPSY SITE IDENTIFIER IS INTENDED FOR USE AFTER AN OPEN SURGICAL OR PERCUTANEOUS BREAST BIOPSY PROCEDURE TO MARK THE BIOPSY SITE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, WHICH PRECLUDES A FULL INVESTIGATION AND ANALYSIS OF THE ROOT CAUSE. OUR MAMMOTOME VACUUM ASSISTED BIOPSY PROBES CONTAIN EXTREMELY SHARP EDGES ALONG THE APERTURE OPENING TO EFFECTIVELY EXCISE TISSUE. REMOVING THE MARKER DELIVERY SYSTEM SEPARATELY FROM THE PROBE APERTURE ONCE THE SPRING IS EXPOSED CREATES THE POSSIBILITY OF IT CATCHING ON ONE OF THESE EDGES. AS A MITIGATION STEP TO ADDRESS THIS RISK, WE PROVIDE INSTRUCTIONS WITHIN THE INSTRUCTIONS FOR USE: DIRECTIONS: REMOVE THE DELIVERY SYSTEM AND MAMMOTOME PROBE TOGETHER AS A SINGLE UNIT FROM THE SITE, PROPERLY DISPOSE AND OBTAIN IMAGES TO CONFIRM MARKER PLACEMENT.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT BY SALES REPRESENTATIVE OF A MAM3008 TIP SHEAR DURING A PROCEDURE. TIP OF DEPLOYMENT DEVICE CUT OFF IN PATIENT. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140046 MAMMOMARK BIOPSY SITE IDENTIFIER NEU DEVICOR MEDICAL PRODUCTS, INC MAM3008 F11924449D 00841911101659

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention