BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME EX BIOPSY SYSTEM

    MDR report key: 8750599 · Received July 1, 2019

    Report

    Report Number
    3008492462-2019-00033
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 1, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    10841911100956
    PMA / PMN Number
    K033700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAMMOTOME EX PROBE IS A STERILE, SINGLE PATIENT USE INSTRUMENT THAT MAY BE USED WITH IMAGING GUIDANCE, SUCH AS ULTRASOUND, TO OBTAIN TISSUE SAMPLES FROM THE BREAST FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. NO ADVERSE EVENT OCCURRED WITH THE USAGE OF THIS PRODUCT. DUE TO THE OPEN PACKAGE THAT CAN POTENTIALLY AFFECT STERILITY, WE CONSIDER THIS EVENT TO BE A PRODUCT MALFUNCTION THAT IF IT WERE TO RECUR, HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE DEVICOR MEDICAL DEVICE (B)(6), STATING, PRIOR TO PROCEDURE PACKAGING IS OPEN, HAS BREAK IN STERILE SEAL. NO PATIENT INVOLVEMENT. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544876 MAMMOTOME EX BIOPSY SYSTEM BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. HH8BEX F11913412D 10841911100956

    Patients

    Seq Age Sex Outcome Treatment
    1