BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME REVOLVE STEREOTACTIC PROB

    MDR report key: 8380151 · Received February 28, 2019

    Report

    Report Number
    3008492462-2019-00010
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 28, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    00841911100713
    PMA / PMN Number
    K152989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVOLVE STEREOTACTIC PROBE IS A STERILE, SINGLE-PATIENT USE DEVICE THAT MAY BE USED WITH IMAGING GUIDANCE TO EXCISE A TISSUE SAMPLE FOR DIAGNOSIS. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. 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 FRANCE, STATING BEFORE THE PROCEDURE THE DISPOSABLE BOX WAS ALREADY OPEN AND THE DEVICE NOT STERILE. 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
    171287 MAMMOTOME REVOLVE STEREOTACTIC PROB BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. MST0809 F11808461D 00841911100713

    Patients

    Seq Age Sex Outcome Treatment
    1