BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPROBE

    MDR report key: 2954004 · Received January 11, 2013

    Report

    Report Number
    2954004
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MAMMOTOME, A DIVISION OF DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    NEOPROBE 2000 GAMMA DETECTION SYSTEM WAS FOUND OUT TO BE NOT WORKING PROPERLY. THERE WAS AN ERROR CODE APPEARING ON THE SCREEN THAT THE EXPECTED NORMAL NUMBER THAT WAS TO APPEAR ON THE SCREEN WASN'T SEEN. MD OPERATED THE EQUIPMENT. CLINICAL ENGINEERING NOTIFIED. NUCLEAR MEDICINE WAS CALLED AND CHECKED THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17117 NEOPROBE COUNTER (BETA, GAMMA) FOR CLINICAL USE IZD MAMMOTOME, A DIVISION OF DEVICOR MEDICAL PRODUCTS, INC. NEOPROBE2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *