BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION¿ ENT NAVIGATION SYSTEM

    MDR report key: 8661288 · Received June 2, 2019

    Report

    Report Number
    1723170-2019-02840
    Event Type
    Malfunction
    Date Received
    June 2, 2019
    Report Date
    June 1, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CART 9733560XOM FUSION EM SYSTEM (SERIAL #: (B)(4)) FOUND (VERBIAGE FROM AFC CODE LEVELS, AS WELL AS ANY AP PLICABLE ANALYSIS SUMMARY NOTES). PRODUCT EVENT SUMMARY #FUSION EMITTER COMMUNICATION PRODUCT ANALYSIS (B)(4): MNAV COMMENT SUBJECT: WORK ORDER (B)(4). MNAV COMMENT ID: CC-1120497. MNAV COMMENT: SUMMARY: WORK ORDER PASSED. 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 EVENT HAVING OCCURRED INTRA-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE EMITTER WAS NOT COMMUNICATING WITH THE FUSION SYSTEM. THEY WERE RECEIVING A RED 'X,' FOR THE EMITTER. SITE USED ANOTHER FUSION FOR THE SURGERY. THE REPRESENTATIVE WAS UNABLE TO PROVIDE CLINICAL DETAILS AND SERIAL NUMBER OF THE FUSION AT THE TIME OF THE CALL. NEW PARAGRAPH BUT SPREADSHEET WON'T ALLOW: CC-1112568 (REP, UF): ADDITIONAL INFORMATION WAS RECEIVED WITH SYSTEM INFORMATION, AS WELL AS IT WAS CONFIRMED THAT THE SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED DURING THE SYSTEM CHECKOUT PROCESS. THE EMITTER WAS TRACKING AND ALL INTERNAL CONNECTIONS WERE SECURE. THE SURGEON NAME WAS PROVIDED AS DR. (B)(6) AND THE PROCEDURE WAS STATED TO HAVE NO DELAY. NO IMPACT TO PATIENT REPORTED. PATIENT DEMOGRAPHICS WERE STATED TO BE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454712 FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM

    Patients

    Seq Age Sex Outcome Treatment
    1