BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM

    MDR report key: 956558 · Received April 24, 2007

    Report

    Report Number
    3003515897-2007-00005
    Event Type
    Malfunction
    Date Received
    April 24, 2007
    Date of Event
    March 30, 2007
    Report Date
    April 24, 2007
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED AND EVALUATION WAS NOT POSSIBLE. THE IFU STATES, "UNUSUAL FORCE APPLIED TO THE NEEDLE/DEVICE, PARTICULARLY DURING INSERTION, COULD BEND AND DAMAGE THE NEEDLE. IF COLLECTING MULTIPLE TISSUE/LESION SAMPLES, INSPECT THE SECURING NEEDLE AND CUTTING CANNULA FOR DAMAGED POINT, BENT SHAFT, OR OTHER IMPERFECTIONS, AFTER EACH SAMPLE IS REMOVED. DO NOT USE IF ANY DAMAGE IS NOTED".

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE CASSI II ROTATIONAL CORE BIOPSY SYSTEM FOR A ULTRASOUND GUIDED BREAST CORE BIOPSY ON A DENSE, 4CM MASS HE FELT WAS A CANCER. THE NEEDLE TIP BROKE OFF WHEN SAMPLING THE LESION. THERE WERE NO REPORTS OF ADDITIONAL COMPLICATIONS FROM THE BIOPSY PROCEDURE. POST-BIOPSY MAMMOGRAM IMAGES WERE OBTAINED WHICH CONFIRMED NEEDLE LOCATION. THE PATIENT WILL HAVE SURGERY TO REMOVE HER CANCER AND THE NEEDLE TIP WILL BE REMOVED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM BIOPSY INSTRUMENT KNW SANARUS MEDICAL, INC. CS2100-NT-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA