BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV 5.5MM TAP (CANNULATED)

    MDR report key: 2881801 · Received December 20, 2012

    Report

    Report Number
    1723170-2012-00757
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. RMA ISSUED. REPLACEMENT PART SHIPPED TO SITE (B)(4) 2012. MEDTRONIC REPRESENTATIVE VISUALLY INSPECTED THE TAP AND FOUND THAT IT IS BLOCKED WITH MATERIAL. NOT ABLE TO REMOVE THE MATERIAL FROM THE TAP.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A LEGACY TAP WAS CLOGGED WITH UNKNOWN MATERIAL. TRIED TO REMOVE WITH A K-WIRE AND COULD NOT REMOVE MATERIAL. THIS WAS A DEMO INSTRUMENT; ISSUE WAS DISCOVERED OUTSIDE OF SURGERY. SINCE THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV 5.5MM TAP (CANNULATED) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 111114

    Patients

    Seq Age Sex Outcome Treatment
    1