BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 PREMIUM SYSTEM

    MDR report key: 8631630 · Received May 22, 2019

    Report

    Report Number
    1723170-2019-02539
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 24, 2019
    Report Date
    July 18, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: (B)(4). DEVICE EVALUATION: THE CAMERA WAS SENT TO THE VENDOR FOR ADDITIONAL INVESTIGATION. VENDOR TESTING CONFIRMED THE FAILURE. THE UNIT WAS RETURNED, AND THE UNIT ALSO PASSED OUTGOING PRODUCT TESTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. HARDWARE PARTS WERE REPLACED. A SYSTEM CHECKOUT WAS PERFORMED AND THE SYSTEM WAS WORKING AS INTENDED. THE CAMERA 9735821 VEGA BASE S8 SVC (LOT# P900796) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THERE WAS AN ELECTRICAL FAILURE. A CHECK OF THE EVENT LOG SHOWED FIRMWARE INCOMPATIBILITY ON (B)(6). AS REPORTED THE PSU FAILED AN ACCURACY TEST AT .32 MM WITH A PASSING THRESHOLD OF .25 MM. IT WAS NOTED THAT MANUFACTURER DATE WAS DECEMBER 2017 AND THAT THE PSU HAD NOT BEEN PREVIOUSLY RETURNED FOR A FAILURE. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. (B)(4). 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. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE CAMERA FAILED AAK TESTING. IT WAS NOTED THAT THE CAMERA WAS STILL FUNCTIONING DESPITE FAILING AAK TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427701 STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1