BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTE

    MDR report key: 934024 · Received October 26, 2007

    Report

    Report Number
    3003515897-2007-00009
    Event Type
    Injury
    Date Received
    October 26, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 25, 2007
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 ATTEMPTED TO USE THE CASSI II ROTATIONAL CORE BIOPSY SYSTEM FOR A CORE BREAST BIOPSY; HOWEVER, THE DEVICE WOULD NOT POWER ON. THE PROCEDURE WAS DISCONTINUED AS THE PHYSICIAN HAD NO OTHER BIOPSY DEVICES AT HIS DISPOSAL. THE PT WAS SCHEDULED FOR AN EXCISIONAL BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTE CASSI II KNW SANARUS MEDICAL, INC. CS2001-S SC070701

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention