BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS CASSI ROTATIONAL CORE BIOPSY SYST

    MDR report key: 630988 · Received July 29, 2005

    Report

    Report Number
    3003515897-2005-00010
    Event Type
    Malfunction
    Date Received
    July 29, 2005
    Date of Event
    July 21, 2005
    Report Date
    July 29, 2005
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CASSI ROTATIONAL CORE BIOPSY DEVICE WAS TRANSPORTED BY A SALES REPRESENTATIVE DURING THE SUMMER HEAT NEAR WASHINGTON DC. THE DEVICES HAD BEEN IN THE CAR MOST OF THE DAY. THE REP REMOVED THE DEVICES, BROUGHT THEM INSIDE AND WAITED ABOUT 30 MINUTES BEFORE DEPLOYING THE DEVICES IN AIR AS A DEMONSTRATION. THE REP ASSEMBLED THE DEVICE PER INSTRUCTIONS AND UPON PRESSING THE SAMPLE BUTTON, THE DEVICE BODY SPLIT. THE SALES REP WAS UNHARMED. THE DEVICE WAS NOT USED IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CASSI ROTATIONAL CORE BIOPSY SYST BIOPSY INSTRUMENT KNW SANARUS MEDICAL, INC. CS1000 CS50504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA