BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOTOME EX BIOPSY SYSTEM

    MDR report key: 9331723 · Received November 15, 2019

    Report

    Report Number
    3008492462-2019-00050
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    October 8, 2019
    Report Date
    November 14, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC
    Product Code
    KNW
    UDI-DI
    10841911100956
    PMA / PMN Number
    KK033700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 EXERCISE A DIAGNOSTIC SAMPLE FROM THE BREAST OR AXILLARY LYMPH NODES FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. DEVICE EVALUATION IS ANTICIPATED, HOWEVER, DEVICOR MEDICAL PRODUCTS, INC. HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION. WE ARE SUBMITTING THIS MEDWATCH REPORT PURSUANT TO 21 CFR 803- IF THE MALFUNCTION WERE TO RE-OCCUR, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT STATING THE KNOCKOUT TIP FELL OFF DURING PROCEDURE. THE BROKEN KNOCKOUT TIP ALMOST GOT INTO THE PATIENT THROUGH THE STEEL TUBE. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD NUMBER 11523686.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121463 MAMMOTOME EX BIOPSY SYSTEM MAMMOTOME EX BIOPSY SYSTEM KNW DEVICOR MEDICAL PRODUCTS INC HH8BEX F11927410D 10841911100956

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention