BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME ELITE PROBE

    MDR report key: 6116736 · Received November 21, 2016

    Report

    Report Number
    3008492462-2016-00051
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    July 26, 2016
    Report Date
    July 29, 2016
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC
    Product Code
    KNW
    PMA / PMN Number
    K112411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/10/2016, ONE MAMMOTOME ELITE ULTRASOUND PROBE (MEP13), LOT NUMBER F11617109D1, WAS RECEIVED FROM THE CUSTOMER FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE CONFIRMED THE USE OF THE DEVICE IN A PROCEDURE. THE DEVICE INITIALIZED NORMALLY, AND SIMULATED FUNCTIONALITY TESTING USING CHICKEN SAMPLES WAS ATTEMPTED. DURING SAMPLING, THE DEVICE DID NOT OBTAIN CHICKEN TISSUE SAMPLES DURING THE FIRST SAMPLING ATTEMPT. ADDITIONAL INVESTIGATION DISCOVERED THAT THE CUTTER WAS CLOGGED WITH TISSUE (ASSUMED BREAST TISSUE, AS DEVICE SHOWED EVIDENCE OF USE IN A CLINICAL PROCEDURE). THE SUSPECTED BREAST TISSUE WAS CLEARED AND THE CUTTER WAS PRIMED WITH SALINE. AFTER THE PRIMING OF THE CUTTER WITH SALINE, THE DEVICE OBTAINED SIX OUT OF SIX CHICKEN SAMPLES SUCCESSFULLY. THE DEVICOR MEDICAL PRODUCTS, INC.'S QUALITY SYSTEM CLASSIFIES THE INITIAL VOICE OF THE CUSTOMER AS A NON-REPORTABLE MALFUNCTION. HOWEVER, DUE TO THE DISCOVERY OF THE ASSUMED BREAST TISSUE WITHIN THE CUTTER, AN ADDITIONAL REPORTABILITY ASSESSMENT WAS CONDUCTED FOR THE ADDITIONAL FAILURE MODE OBSERVED WITHIN THE INVESTIGATION. THIS FAILURE MODE DISCOVERED DURING THE INVESTIGATION WAS DETERMINED TO BE A REPORTABLE MALFUNCTION, PURSUANT TO 21 CFR §803 BECAUSE THIS MALFUNCTION HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AS A RESULT OF POTENTIAL MISSED OR LOST TISSUE SAMPLES. THE ROOT CAUSE FOR THIS MALFUNCTION IS UNKNOWN, BUT PREVIOUS ASSESSMENTS OF SIMILAR EVENTS HAVE DETERMINED IT RELATES TO ONE OR A COMBINATION OF SEVERAL POSSIBILITIES, INCLUDING INADEQUATE VACUUM DEVELOPED AT THE TISSUE COLLECTION CHAMBER, OR EXCESS FRICTION BETWEEN THE TISSUE SAMPLE AND THE INTERNAL SURFACE OF THE CUTTER.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE PROBE DID NOT PROVIDE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768190 MAMMOTOME ELITE PROBE BIOPSY PROBE KNW DEVICOR MEDICAL PRODUCTS, INC MEP13 F11617109D1

    Patients

    Seq Age Sex Outcome Treatment
    1