BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME ELITE BIOPSY PROBE

    MDR report key: 8599310 · Received May 10, 2019

    Report

    Report Number
    3008492462-2019-00019
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    January 8, 2019
    Report Date
    May 10, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    KNW
    UDI-DI
    00841911100898
    PMA / PMN Number
    K153709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEP13 PROBES ARE STERILE, SINGLE USE DEVICES, INDICATED TO OBTAIN TISSUE SAMPLES FROM THE BREAST OR AXILLARY LYMPH NODES FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. ONE MEP13 DEVICE WAS RETURNED FOR INVESTIGATION. BREAST TISSUE WAS FOUND IN THE BASKET PRIOR TO INITIALIZATION. THE PROBE WAS PULLING ADEQUATE VACUUM; HOWEVER, DRIED BLOOD PREVENTED TISSUE FROM TRANSPORTING. DUE TO THE DISCOVERY OF THE TISSUE, THIS EVENT WAS ASSESSED AGAINST THE RESULT OF THE INVESTIGATION. FOLLOWING CONSULTATION WITH OUR MEDICAL DIRECTOR, DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AS A RESULT OF POTENTIAL MISSED OR LOST TISSUE SAMPLES, PURSUANT TO 21 CFR §803, THIS FAILURE MODE WAS DETERMINED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE, DEVICOR MEDICAL (B)(4), STATING, "NO TISSUE SAMPLE ACQUIRED. THE NEW PROBE WAS USED AND THE PROCEDURE WAS COMPLETED". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391895 MAMMOTOME ELITE BIOPSY PROBE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS INC. MEP13 F11837202D 00841911100898

    Patients

    Seq Age Sex Outcome Treatment
    1