BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME SYSTEM CONTROL MODULE

    MDR report key: 8641879 · Received May 24, 2019

    Report

    Report Number
    3008492462-2019-00024
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 25, 2019
    Report Date
    May 24, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    0084191110059
    PMA / PMN Number
    K042753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAMMOTOME BIOPSY SYSTEM IS INDICATED TO PROVIDE TISSUE SAMPLES FOR DIAGNOSTIC SAMPLING OF BREAST ABNORMALITIES. THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. EVALUATION PENDING. ALTHOUGH THERE WAS NO PATIENT CONSEQUENCE, DUE TO THE REMOTE POTENTIAL OF THIS MALFUNCTION TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AS A RESULT OF A POTENTIAL DEVICE FIRE, THIS HAS BEEN DETERMINED TO BE REPORTABLE PURSUANT TO 21 CFR 803.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM A USER FACILITY STATING, "MAMMOTOME CONTROL MODULE WAS GENERATING A BURNING SMELL DURING SETUP, DURING PROCEDURE, AND AFTER PROCEDURE". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433539 MAMMOTOME SYSTEM CONTROL MODULE BIOPSY SYSTEM KNW DEVICOR MEDICAL PRODUCTS, INC. SCM12 N/A 0084191110059

    Patients

    Seq Age Sex Outcome Treatment
    1