BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME REVOLVE STEROTACTIC PROBE

    MDR report key: 9159416 · Received October 4, 2019

    Report

    Report Number
    3008492462-2019-00046
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 4, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC
    Product Code
    KNW
    UDI-DI
    00841911100744
    PMA / PMN Number
    K152989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MST1009 PROBES ARE STERILE, SINGLE USE DEVICES, INDICATED TO OBTAIN TISSUE SAMPLES FROM THE BREAST OR AXILLARY LYMPH NODES FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. IF THE TISSUE IS FOUND WITHIN THE CANISTER RATHER THAN IN THE SAMPLE MANAGMENT SYSTEMS, A MISDIAGNOSIS IS POSSIBLE DUE TO LOST TISSUE. FOLLOWING CONSULATATION 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 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)(6) STATING THAT "TISSUE SAMPLES BYPASSED THE COLLECTION CUP AND WENT STRAIGHT INTO THE CANISTER. AFTER THE PROCEDURE, WHEN THEY CHECKED THE CANISTER, THERE WAS A LOT OF ADIPOSE TISSUES. ALSO THEY FOUND A CALCIFIED TISSUE IN IT. 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
    951794 MAMMOTOME REVOLVE STEROTACTIC PROBE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC MST1009 F11914472D 00841911100744

    Patients

    Seq Age Sex Outcome Treatment
    1