BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMTOME REVOLVE ULTRASOUND PROBE

    MDR report key: 8451170 · Received March 26, 2019

    Report

    Report Number
    3008492462-2019-00015
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    February 15, 2019
    Report Date
    March 26, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    KNW
    UDI-DI
    10841911100819
    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 HAS NOT YET BEEN RECEIVED BY 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 LINE 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 OUR (B)(6) AFFILIATE STATING, DURING A BREAST BIOPSY PROCEDURE, THE SAMPLES WERE STUCK IN THE VACUUM LINE WHERE THEY ARE NOT SUPPOSED TO ENTER. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247501 MAMMTOME REVOLVE ULTRASOUND PROBE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS INC. MHUS08 F11850228D 10841911100819

    Patients

    Seq Age Sex Outcome Treatment
    1