BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8G X 12 MAMMOTOMESTEREOTACTIC PROBE

    MDR report key: 8767943 · Received July 8, 2019

    Report

    Report Number
    3008492462-2019-00035
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 8, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    10841911100727
    PMA / PMN Number
    K152989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DIAGNOSIC ANALYSIS OF BREAST ABNORMALITIES. THE DEVICE WAS NOT RETURNED TO DEVICOR MEDICAL PRODUCTS, INC. FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED INCIDENT. IF THE TISSUE IS FOUND WITHIN THE VACUUM TUBING RATHER THAN IN THE SAMPLE MANAGEMENT SYSTEM, A MISDIAGNOSIS IS POSSIBLE DUE TO LOST TISSUE. 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 (B)(6) GMBH, STATING, "DURING PROCEDURE SAMPLES WERE NOT COLLECTED IN THE CHAMBERS, THEY WENT TO THE TUBING. NO PATIENT COMPLICATIONS". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562716 8G X 12 MAMMOTOMESTEREOTACTIC PROBE BIOPSY SYSTEM KNW DEVICOR MEDICAL PRODUCTS, INC. MST0812 F11847472D 10841911100727

    Patients

    Seq Age Sex Outcome Treatment
    1