BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV 5.5MM TAP (CANNULATED)

    MDR report key: 3884987 · Received June 19, 2014

    Report

    Report Number
    1723170-2014-00664
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # NOW PROVIDED.MFG DATE NOW PROVIDED. EVALUATION OF SUSPECT TAP FOUND THAT AS REPORTED, A GUIDE WIRE HAS BEEN BROKEN OFF INSIDE THE TAP.

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. RMA ISSUED. REPLACEMENT 5.5 CANNULATED TAP SHIPPED TO SITE (B)(4) 2014. SUSPECT PART NOT RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED A GUIDE WIRE BECAME LODGED IN A 5.5 TAP. THIS OCCURRED WHEN ATTEMPTS WERE MADE TO REMOVE MATERIAL FROM THE TAP CANNULA. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361960 NAV 5.5MM TAP (CANNULATED) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 100525

    Patients

    Seq Age Sex Outcome Treatment
    1