BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11607601 · Received April 2, 2021

    Report

    Report Number
    1723170-2021-00876
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 2, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 733449, SERIAL/LOT #: (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 SYSTEM BEING USED DURING A FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION WAS BEING VERIFIED AT THE BEGINNING OF THE PROCEDURE ALONG WITH THE 70 DEGREE OLIVE TIP SUCTION. THE ONLY WAY THE RESIDENT WAS ABLE TO GET THE STRAIGHT SUCTION TO VERIFY WAS TO HOLD IT ALMOST TOUCHING THE PATIENT'S NOSE - A VERY AWKWARD POSITION. WHEN HELD IN THE NORMAL POSITION (PERPENDICULAR TO THE DIVOT) IT WAS VERIFYING AT 3.5MM + DISTANCE TO DIVOT. THE SITE CONTINUED TO USE THIS SUCTION AND THE REP STATED IT MIGHT CAUSE INACCURACY ISSUES. THEY CHOSE TO USE THE OTHER INSTRUMENTS IN THE TRAY WHEN ACCURACY MATTERED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504291 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR