BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NODE SEEKER

    MDR report key: 5267523 · Received December 1, 2015

    Report

    Report Number
    MW5058289
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    October 23, 2015
    Report Date
    December 1, 2015
    Manufacturer
    INTRAMEDICAL IMAGING LLC
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT TOTAL MASTECTOMY AND SENTINEL NODE BIOPSY, THE WIRELESS NODE SEEKER PROBE MALFUNCTIONED. THE WIRELESS NODE SEEKER PROBE WOULD NOT SYNC WITH THE NODE SEEKER CONTROL UNIT. AS A RESULT, THE OPERATION WAS PROLONGED WHILE OBTAINING A FUNCTIONING NODE SEEKER PROBE FROM ANOTHER LOCATION. THE NODE SEEKER PROBE WAS SENT TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789412 NODE SEEKER SEED DETECTOR IZD INTRAMEDICAL IMAGING LLC INTRAMEDICAL IMAGING S# IMI-NS-1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other