BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NODE SEEKER

    MDR report key: 2403708 · Received January 3, 2012

    Report

    Report Number
    MW5023728
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 3, 2012
    Manufacturer
    INTRAMEDICAL IMAGING, LLC
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BREAST SERVICE RECENTLY PURCHASED A NEW NODE SEEKER DEVICE (INSTRAMEDICAL IMAGING) TO REPLACE THE OLD C TRACKS. THE BATTERIES USED IN THE NEW DEVICE APPEAR TO HAVE SOME DEFECT. IN THE FIRST INSTANCE, THE BATTERY HEATED UP AND LEAKED INSIDE THE PROBE A MONTH AGO. TODAY THE BATTERY SUPPLIED BY THE VENDOR EXPLODED AND SHREDDED INSIDE THE CHARGER. I CANNOT UPLOAD A PHOTO TO THIS SITE OR I WOULD SHOW THE EXPLOSIVE AFTERMATH. REASON FOR USE: SENTINEL LYMPH NODE BIOPSY IN BREAST CANCER AND MELANOMA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NODE SEEKER GAMMA SEED DETECTOR 3.6V IZD INTRAMEDICAL IMAGING, LLC
    2 ULTRA FIRE BATTERY BATTERY 1000MAH IZD INTRAMEDICAL IMAGING, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1