BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT

    MDR report key: 10710651 · Received October 21, 2020

    Report

    Report Number
    10710651
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    June 18, 2020
    Report Date
    September 29, 2020
    Manufacturer
    CIANNA MEDICAL, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGERY INVOLVED EXCISION OF A CLIPPED LYMPH NODE WITH SAVI LOCALIZATION. THERE WAS NO SIGNAL THAT COULD BE DETECTED WITH THE SAVI PROBE, EITHER AT THE START OF THE CASE (PRIOR TO INCISION), OR DURING THE CASE WHEN EXAMINING THE AXILLARY WOUND OR THE AXILLARY SPECIMEN. THE PROBE WAS WORKING WHEN TESTED WITH THE TEST CARD. THE SPECIMEN DID CONTAIN A SAVI MARKER CONFIRMED ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174967 SAVI SCOUT MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CIANNA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA