BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE

    MDR report key: 3840230 · Received May 7, 2014

    Report

    Report Number
    3840230
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVED IN INTERVENTIONAL RADIOLOGY DEPARTMENT FOR LIVER BIOPSY. ATTENDING PHYSICIAN PERFORMING PROCEDURE. AFTER OBTAINING THE FIRST SAMPLE WITH BIOPINCE BIOPSY GUN, THE PHYSICIAN HAD NOTICED THAT IT WAS DIFFICULT TO OBTAIN SAMPLE AND THE TIP OF THE DEVICE WAS SLIGHTLY CURVED. NO SAMPLE WAS OBTAINED WITH THE FIRST DEVICE. AT THAT POINT THE BIOPSY DEVICE WAS EXCHANGED FOR A NEW BIOPSY DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS AND ALL SAMPLES WERE SENT TO THE LAB. NO HARM WAS CAUSED TO PATIENT.======================MANUFACTURER RESPONSE FOR FULL CORE BIOPSY INSTRUMENT, BIOPINCE (PER SITE REPORTER).======================AS OF THIS REPORT, FIELD REP IS EN ROUTE TO PICK UP DEFECTIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274767 BIOPINCE INSTRUMENT, BIOPSY KNW ARGON MEDICAL DEVICES INC. * 110661893

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR