BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME REVOLVE STEREOTACTIC PROBE - 10G

    MDR report key: 8379682 · Received February 28, 2019

    Report

    Report Number
    3008492462-2019-00012
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 28, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    PMA / PMN Number
    K152989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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 CANISTER 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 JAPAN STATING, THE SAMPLES OBTAINED DURING THE PROCEDURE WERE SMALL, UPON CHECKING THE CANISTER THERE WERE TISSUE SAMPLES IN THE CANISTER. NO PATIENT COMPLICATIONS. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173613 MAMMOTOME REVOLVE STEREOTACTIC PROBE - 10G BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. MST1009 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1