BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8517023 · Received April 16, 2019

    Report

    Report Number
    1723170-2019-01767
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 19, 2018
    Report Date
    April 16, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF CASE PART 253134 FOUND THAT THE CAMERA OR SCU WAS DAMAGED. ANALYSIS OF CASE PART 253135 FOUND NO ANOMALIES. THE RETURNED PSU'S HOUSING HAS YELLOWED CONSIDERABLY. BOTH LENSES HAVE MANY SCRATCHES. A CHECK OF THE EVENT LOG DID NOT REVEAL ANY ADVERSE EVENTS. THE PSU PASSED AN ACCURACY TEST AT .19 MM WITH A PASSING THRESHOLD OF .35 MM, BUT THE PSU HAD DIFFICULTY TRACKING IN THE LOWER REACHES AT THE BACK EDGE OF THE VOLUME, POSSIBLY DUE TO THE SCRATCHED LENSES. ALSO, THE LASER BATTERY IS LOW, ONLY ABLE TO LIGHT THE LASER BRIEFLY. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT, DURING TESTS, IT SEEMED LIKE THE CAMERA FIELD WAS SHORTER THAN IT SHOULD BE. THE FIELD HAD TO BE PUT CLOSER THAN USUAL. THERE WAS NOT PATIENT PRESENT WHEN THE ISSUE WAS ADDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313771 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1