BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM

    MDR report key: 938713 · Received November 5, 2007

    Report

    Report Number
    3003515897-2007-00010
    Event Type
    Injury
    Date Received
    November 5, 2007
    Date of Event
    October 3, 2007
    Report Date
    November 5, 2007
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO USE THE CASSI II ROTATIONAL CORE BIOPSY SYSTEM FOR A AXILLARY LYMPH NODE BIOPSY; HOWEVER, NO SAMPLES WERE OBTAINED. SURGERY WILL BE SCHEDULED. AS OF CONTACT DATE 2007, THE PATIENT HAS LEFT THIS PRACTICE FOR TREATMENT ELSEWHERE; THEREFORE, ADDITIONAL INFORMATION REGARDING ADDITIONAL SURGICAL PROCEDURE IS NOT AVAILABLE.

    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. CS2120-NT-1 CX070701

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention