BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMTOME REVOLVE ULTRASOUND PROBE

    MDR report key: 8518465 · Received April 16, 2019

    Report

    Report Number
    3008492462-2019-00018
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 16, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    KNW
    UDI-DI
    00841911100812
    PMA / PMN Number
    K152989
    Adverse Event
    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 AFFILIATE, DEVICOR MEDICAL (B)(4), STATING, DURING A BREAST BIOPSY PROCEDURE, AFTER 3-4 SAMPLES WERE TAKEN, A 603 ERROR MESSAGE OCCURRED AND ONE OF THE SAMPLE IS IN THE VACUUM TUBING LINE. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312300 MAMMTOME REVOLVE ULTRASOUND PROBE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS INC. MHUS08 F11838465D 00841911100812

    Patients

    Seq Age Sex Outcome Treatment
    1