BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 9722739 · Received February 18, 2020

    Report

    Report Number
    1723170-2020-00564
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 18, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733597, SERIAL/LOT #: 160526. NO PATIENT INVOLVED. ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. HARDWARE PARTS WERE REPLACED AND THE ISSUE WAS RESOLVED. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS RETURNED TO AN OPERATIONAL CONDITION. THE CABLE WAS RETURNED TO MANUFACTURER FOR ANALYSIS. FUNCTIONAL TESTING DETERMINED THAT THE CABLE JACKET HAS SEPARATED AT THE LEMO CONNECTOR EXPOSING THE SHIELD WIRE BUT NO BARE CONDUCTORS. THE SHIELD WIRE IS ALSO DAMAGED WITH MOST OF THE WIRE SEVERED. A CONTINUITY TEST REVEALED OPENS AT PINS 2 AND 4 OF THE USB CABLE. 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 USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE AXIEM POWER/COMMUNICATION CABLE IS STARTING TO FRAY. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186410 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1