BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST BIOPSY SITE MARKER

    MDR report key: 7066769 · Received November 29, 2017

    Report

    Report Number
    7066769
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    June 14, 2017
    Report Date
    November 15, 2017
    Manufacturer
    DEVICOR MEDICAL PRODUCTS
    Product Code
    IZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CIRCULATOR AND LUNCH RELIEF SCRUB TECH WITH DOCTORS WERE PERFORMING SENTINEL NODE BIOPSY. WE SUCCESSFULLY LINKED NEOPROBE AT BEGINNING OF CASE AND WORKED FOR FIRST NODE. WE WERE ABLE TO USE TO FIND SECOND NODE AND WHILE GETTING EX-VIVO COUNT NEOPROBE STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847046 BREAST BIOPSY SITE MARKER NEOPROBE IZD DEVICOR MEDICAL PRODUCTS BLUETOOTH II

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR