BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME ELITE BIOPSY PROBE

    MDR report key: 10875454 · Received November 20, 2020

    Report

    Report Number
    3008492462-2020-00010
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 19, 2020
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC
    Product Code
    KNW
    UDI-DI
    00841911100898
    PMA / PMN Number
    K153709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT AFTER THE SAMPLING, THERE WAS CONSIDERABLE BLEEDING WHEN THE NEEDLE WAS REMOVED FROM THE PATIENT. WHEN THE DOCTOR LOOKED AT THE NEEDLE TIP, THE TIP WAS BENT. THIS INCIDENT IS DOCUMENTED AS COMPLAINT (B)(4). NO SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342672 MAMMOTOME ELITE BIOPSY PROBE BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS INC MEP13 F12003405D 00841911100898

    Patients

    Seq Age Sex Outcome Treatment
    1