BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST 960-539 GUIDE BIOPSY

    MDR report key: 10257749 · Received July 10, 2020

    Report

    Report Number
    1723170-2020-01896
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 10, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE NOT AVAILABLE ON THE DATE OF FILING. THE INSTRUMENT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE REPORTED ISSUE WAS CONFIRMED, THE LOWER JOINT WILL NOT LOCK DOWN COMPLETELY WHEN THE KNOB IS TIGHTENED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE NAC TRAY PRECISION AIMING DEVICE (PAD) WILL NOT FULLY TIGHTEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724279 INST 960-539 GUIDE BIOPSY INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 960-539 106031

    Patients

    Seq Age Sex Outcome Treatment
    1