BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT REFLECTOR AND DELIVERY SYSTEM

    MDR report key: 14117469 · Received April 15, 2022

    Report

    Report Number
    14117469
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 5, 2022
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD UNDERGONE SAVI SCOUT LOCALIZATION OF CORK CLIP PLACED AT MR BIOPSY OF RIGHT BREAST NME DETECTED ON HIGH RISK SCREENING STUDY. THE BIOPSY RETURNED PAPILLARY LESION WITH ADH, SCLEROSING ADENOSIS COLUMNAR CELL CHANGE AND FIBROCYSTIC CHANGE. AT LOCALIZATION PER NOTE OF DR. THERE WAS SIGNAL DETECTED FROM THE SAVI SCOUT DEVICE. 6 DAYS LATER, WAS CONTACTED BY THE OR RADIOLOGY TECH TO REVIEW SPECIMEN RADIOGRAPH. THERE WAS NO SAVI SCOUT OR CORK CLIP EVIDENT IN THE SPECIMEN. I CONTACTED OR DR. BY PHONE IN THE O.R. IMMEDIATELY AFTER THE FIRST FILM. SHE STATED SHE COULD NOT GET RELIABLE SIGNAL AND WAS GOING TO TRY TO USE ANOTHER DETECTION UNIT. A SECOND SPECIMEN ARRIVED AND NO SAVI SCOUT OR CORK CLIP WAS EVIDENT. I IMMEDIATELY CALLED THE O.R. AND CONFIRMED THIS WITH DR. SHE REPORTED SHE WAS NOT GOING TO ATTEMPT TO OBTAIN ANY MORE TISSUE SAMPLES. PATIENT DOES NOT NEED ANY ADDITIONAL PROCEDURES RELATED TO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907515 SAVI SCOUT REFLECTOR AND DELIVERY SYSTEM MARKER, RADIOGRAPHIC, IMPLANTABLE NEU MERIT MEDICAL SYSTEMS, INC. H2234004

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Female