BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT

    MDR report key: 8662480 · Received June 3, 2019

    Report

    Report Number
    1723170-2019-02864
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 6, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K153247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. FACILITY THIS ISSUE OCCURRED AT IS UNKNOWN AT THE TIME OF FILING. FOLLOW-UP IS BEING CONDUCTED. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THERE WAS AN ERROR IMPORTING SOME STUDIES. AN ADDITIONAL SYSTEM CHECKOUT WAS PERFORMED AND FOUND THAT THE SYSTEM WAS PERFORMING AS INTENDED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. A SOFTWARE INVESTIGATION ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE THROUGH DESIGN ANALYSIS. ANALYSIS FOUND THAT THE SOFTWARE WAS FUNCTIONED AS DESIGNED. THE IMPORTED EXAMS IMAGES WERE MORE THAN THE SUPPORTED RESOLUTION. DEVICE MANUFACTURING DATE IS UNAVAILABLE. 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 BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT PRE-OPERATIVELY, THERE WERE TWO STUDIES FROM THE SAME HOSPITAL THAT THE SYSTEM DID NOT RECOGNIZE. THEY HAD BEEN IMPORTED FROM A CD AND A USB BUT IN BOTH CASES THE SYSTEM DID NOT IMPORT THEM. THE SITE RECEIVED THE FOLLOWING ERROR MESSAGE: SOME OR ALL OF THE INFORMATION WHICH IS STORED WITH EACH SLICE OF THE EXAM IS INVALID. CHECK TO VERIFY THAT THE EXAM WAS SCANNED AND ARCHIVED ACCORDING TO PROTOCOL. THE SITE WAS ABLE TO USE NAVIGATION USING ANOTHER IMAGE. THE PROCEDURE WAS COMPLETED WITH LESS THAN ONE HOUR DELAY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. A MANUFACTURE REPRESENTATIVE LOADED THE EXAM INTO THEIR LAPTOP AND OPENED THEM WITH NO PROBLEM BUT ONCE THEY WERE EXPORTED AND ATTEMPTED TO BE IMPORTED INTO THE NAVIGATION SYSTEM THROUGH A USB, IT DID NOT WORK. THE EXAM WAS REVIEWED AND FOUND THAT SEVERAL EXAMS IN THE SET WERE EVALUATED. IT WAS NOTED THAT ALL IMAGES WERE OVER 1MB IN SIZE, IN ADDITION, THE X/Y (COLUMN/ROW) WERE 768X768.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456131 FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9735602

    Patients

    Seq Age Sex Outcome Treatment
    1