BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 8489989 · Received April 7, 2019

    Report

    Report Number
    1723170-2019-01580
    Event Type
    Malfunction
    Date Received
    April 7, 2019
    Report Date
    April 7, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733823, SERIAL/LOT #: (B)(4). A CABLE WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THE CABLE WAS DAMAGED AND PINS 11A AND 4A WERE SEVERELY BENT ON THE ODU-MAC CONNECTOR. SEVERAL OTHERS ARE SLIGHTLY BENT. A CONTINUITY TEST REVEALED AN OPEN FROM PIN 3B OF THE ODU-MAC CONNECTOR TO PIN 3 OF THE LARGE LEMO CONNECTOR. 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 DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE MICROSCOPE CABLE WAS DAMAGED. THIS WAS REPORTED OUTSIDE OF A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282981 STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733927

    Patients

    Seq Age Sex Outcome Treatment
    1