BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY GUIDE

    MDR report key: 3935701 · Received July 15, 2014

    Report

    Report Number
    1723170-2014-00756
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A BIOPSY GUIDE THAT WOULD NOT TIGHTEN PROPERLY; THE BOTTOM JOINT THAT ALLOWS FOR 360 DEGREE ROTATION DOES NOT TIGHTEN ENOUGH WHEN USING FIGURES. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411962 BIOPSY GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 020211

    Patients

    Seq Age Sex Outcome Treatment
    1