BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8G X 12 MAMMOTOME STEREOTACTIC PROBE

    MDR report key: 7754360 · Received August 6, 2018

    Report

    Report Number
    3008492462-2018-00053
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 6, 2018
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC
    Product Code
    KNW
    UDI-DI
    00841911100720
    PMA / PMN Number
    K152989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAMMOTOME REVOLVE DUAL VACUUM ASSISTED BIOPSY SYSTEM IS INTENDED TO OBTAIN TISSUE SAMPLES FROM THE BREAST OR AXILLARY NODES FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, WHICH PREVENTS A FULL INVESTIGATION AND ANALYSIS OF THE ROOT CAUSE AT THIS TIME. HOWEVER, THIS FAILURE MODE HAS BEEN REVIEWED BY OUR MEDICAL ADVISOR AND IDENTIFIED IN THE RISK MANAGEMENT FILE FOR PERFORMANCE EXPECTATIONS. THE DEVICE IS INTENDED TO BE USED BY A TRAINED PROFESSIONAL WHO IS FAMILIAR WITH PRECAUTIONS RELATED TO BLOOD BORNE PATHOGEN EXPOSURE WHEN COMPLETING A BIOPSY PROCEDURE. HOWEVER, EJECTION WITH VELOCITY IS NOT EXPECTED BY THE USER AND HAS GREATER CHANCE TO HARM THAN FLUID EGRESSION INCLUDING, BUT NOT LIMITED TO, THE FLUID ENTERING MUCOUS MEMBRANES. THE DEVICE IS NOT MEETING ITS INTENDED PERFORMANCE SPECIFICATION AND CLAIMS AND IS CONSIDERED TO HAVE MALFUNCTIONED. THE PATIENT OR USER MAY BE EXPOSED TO BIOLOGICAL HAZARDS RESULTING IN INFECTION OR CROSS-CONTAMINATION. ALTHOUGH NO SERIOUS INJURIES HAVE OCCURED, THIS FAILURE MODE HAS BEEN EVALUATED BY OUR MEDICAL ADVISOR AND BASED ON POTENTIAL FOR CROSS CONTAMINATION OR INFECTION DUE TO POSSIBLE EXPOSURE TO BODY FLUIDS, IT HAS BEEN DETERMINED TO BE A REPORTABLE MALFUNCTION. THUS, PURSUANT TO 21 CFR 803, WE ARE SUBMITTED THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE, THE CUSTOMER HAD 3 TIMES LATELY WHERE BLOOD/FLUID "SHOT/SPRAYED OUT" THE BACK OF THE SPECIMEN CHAMBER DURING A PROCEDURE. PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594658 8G X 12 MAMMOTOME STEREOTACTIC PROBE BIOPSY SYSTEM, KNW DEVICOR MEDICAL PRODUCTS INC MST0812 F11817453D 00841911100720

    Patients

    Seq Age Sex Outcome Treatment
    1