BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMTOME REVOLVE ULTRASOUND PROBE

    MDR report key: 8772571 · Received July 9, 2019

    Report

    Report Number
    3008492462-2019-00036
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    April 11, 2019
    Report Date
    July 9, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    00841911100812
    PMA / PMN Number
    K152989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MHUS08 PROBES ARE STERILE, SINGLE USE DEVICES, INDICATED TO OBTAIN TISSUE SAMPLES FROM THE BREAST OR AXILLARY LYMPH NODES FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. THE DEVICE WAS RETURNED TO DEVICOR FOR INVESTIGATION. BREAST TISSUE FOUND IN CUP UPON RECEIPT. THE CUTTER GEAR WAS BOUND AND COULD NOT BE FREED BY HAND; HOWEVER, DEVICE INITIALIZED WHEN PLACED ON HOLSTER. THE DEVICE RETRIEVED 4/4 CHICKEN, USED AS SAMPLE MEDIUM, WITHOUT ISSUE. DUE TO THE DISCOVERY OF BREAST 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 AFFILIATE DEVICOR MEDICAL DEVICE (B)(4) CO. STATING, "DURING PROCEDURE INADEQUATE TISSUE OR NO TISSUE AND ERROR CODE 804/808 AFTER 1-5 CUTS". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564528 MAMMTOME REVOLVE ULTRASOUND PROBE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. MHUS08 F11906481D 00841911100812

    Patients

    Seq Age Sex Outcome Treatment
    1