BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM

    MDR report key: 1327440 · Received February 24, 2009

    Report

    Report Number
    3003515897-2009-00001
    Event Type
    Injury
    Date Received
    February 24, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 24, 2009
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED AND EVALUATION WAS NOT POSSIBLE, AND NO MALFUNCTION COULD BE CONFIRMED.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO USE THE ROTATIONAL CORE BIOPSY SYSTEM FOR A BREAST BIOPSY; HOWEVER, THE SAMPLES THAT WERE OBTAINED WERE NOT SATISFACTORY TO THE PHYSICIAN. BECAUSE OF THIS, THE PATIENT WAS SENT TO ANOTHER FACILITY TO REPEAT THE BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM CASSI II KNW SANARUS MEDICAL, INC. CS2100-NT-1 C2080901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention