BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE DISP. AUTO. BIOPSY INSTRUMENT

    MDR report key: 1734805 · Received June 3, 2010

    Report

    Report Number
    1036710-2010-00018
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 6, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K904987A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE CUTTING CANNULAS ARE DEFORMED. ON THE RETURNED DEVICE IT APPEARS THE STYLET WENT THROUGH THE PINCER WINDOW IN THE PROCESS OF COCKING. IF THIS OCCURRED, ONCE THE DEVICE WAS FIRED THE PINCER MAY BEND OUT AND CURVE AS EXPERIENCED. THERE IS NO DAMAGE TO THE STYLET. A REVIEW OF DHRS FOUND NO RELATED DEFECTS DURING IN-PROCESS INSPECTIONS FOR THE PAST 24 MONTHS. A REVIEW OF COMPLAINTS FOUND THREE RELATED COMPLAINTS IN THE PAST 24 MONTHS. IN TWO CASES THERE WAS PINCER DAMAGE, BUT NOT CANNULA DAMAGE AS EXPERIENCED IN THIS REPORT. IN THE OTHER CASE THERE WAS A GALL MARK ON THE CANNULA CAUSED BY INTERFERENCE WITH ANOTHER DEVICE. IN THIS CASE, THE CUSTOMER STATES THE GUN WAS INSERTED AND FIRED FOR COLLECTION OF THE FIRST SAMPLE. UPON REMOVAL THERE WAS SKIN TENTING. THE PHYSICIAN WENT TO GO FOR A SECOND PASS, BUT DID NOT FIRE DUE TO THE SKIN TENTING. TESTING WAS CONDUCTED ON THE UNUSED BIOPINCE DEVICES RETURNED WITH THE CONTAMINATED SAMPLES. THERE WAS NO DAMAGE OR ABNORMALITIES ON THE UNUSED DEVICES OUT OF THE PACKAGING. THE DEVICES WERE DRY FIRED AND TESTED IN BEEF KIDNEY WITH NO ABNORMALITIES. SINCE THERE WAS NO DAMAGE TO THE STYLET, A POTENTIAL ROOT CAUSE FOR THE DEFECT REPORTED AS IF THE INSTRUMENT HIT DENSE/HARD TISSUE AFTER BEING FIRED. WE WERE ABLE TO DUPLICATE THE CONDITION OF THE NEEDLE BY COCKING AND FIRING THE DEVICE WITH DAMAGED CANNULA TIPS. AFTER INVESTIGATION IT DOES NOT APPEAR THE DEFECT IS RELATED TO THE MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT BIOPINCE DEVICE NEEDLE TIPS BENT OUTWARD ON TWO DIFFERENT PATIENTS CAUSING TISSUE DAMAGE UPON EXIT. SPECIMENS WERE FRAGMENTED AND PATIENT WAS MONITORED AND HAD TWO ULTRASOUNDS TO CHECK FOR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPINCE DISP. AUTO. BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 370-1080-01 93481YEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other