BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME ELITE BIOPSY PROBE

    MDR report key: 8312805 · Received February 6, 2019

    Report

    Report Number
    3008492462-2019-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 14, 2019
    Report Date
    January 14, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    PMA / PMN Number
    K153709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEP13 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. AS THE TISSUE WAS RETURNED TO THE BASKET UPON INITIALIZATION, PRIOR TO A SUBSEQUENT USE, 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. HAS RECEIVED A REPORT FROM THE END USER STATING, "PHYSICIAN ATTEMPTED 4 PASSES BUT RECEIVED NO TISSUE. PROBE WAS SET ASIDE. LATER IN THE DAY, PROBE WAS AGAIN ATTACHED TO A HOLSTER AND DURING INITIALIZATION, A PIECE OF SAMPLE TISSUE WAS DEPOSITED IN THE BASKET." THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103145 MAMMOTOME ELITE BIOPSY PROBE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. MEP13 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1