BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM

    MDR report key: 873765 · Received June 29, 2007

    Report

    Report Number
    3003515897-2007-00007
    Event Type
    Injury
    Date Received
    June 29, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 29, 2007
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED AND EVALUATION WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE CASSI II ROTATIONAL CORE BIOPSY SYSTEM FOR A CORE BREAST BIOPSY. DURING THE PROCEDURE, THE PHYSICIAN DID NOT RECEIVE A SAMPLE. THE PROCEDURE WAS DISCONTINUED AND THE PHYSICIAN RESCHEDULED THE PT FOR A SECOND PROCEDURE.

    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-BK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention