BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SUCTION, AXIEM¿

    MDR report key: 2771966 · Received October 4, 2012

    Report

    Report Number
    1723170-2012-00555
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS UNKNOWN AT THIS TIME. A REPLACEMENT STRAIGHT SUCTION WAS SENT TO THE SITE FOR RESOLUTION. THE SUSPECT STRAIGHT SUCTION DEVICE FUNCTIONED PROPERLY DURING MANUFACTURER TESTING. IT VERIFIES IN THE DIVOT WITH AN ACCEPTABLE GEOMETRY VALUE. NAVIGATION LOOKS NORMAL. UNABLE TO CONFIRM COMPLAINT.

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER HAS BEEN CORRECTED AS IT WAS INITIALLY REPORTED TO BE #8664 BUT IN FACT IS # 73673400.DEVICE MANUFACTURE DATE PROVIDED.

    Additional Manufacturer Narrative · 1

    A SECOND SUCTION PROBE WAS RETURNED FROM THE SITE. THIS SUCTION DISPLAYED THE REPORTED BEHAVIOR. IT IS LIKELY THAT THE SITE ACCIDENTALLY SENT BACK THE NEW SUCTION INSTEAD OF THE DEFECTIVE SUCTION WITH THE FIRST RETURN MATERIALS AUTHORIZATION (RMA) AND THEN HAD TO ORDER ANOTHER ONE, ASSUMING THAT THE ONE THEY KEPT (WHICH WAS LIKELY THE ORIGINAL SUCTION) WAS BAD AT INSTALL (BAI). THE FIRST SUCTION RECEIVED BACK WAS FOUND TO BE FULLY FUNCTIONAL, THE SECOND SUCTION RECEIVED BACK DISPLAYED THE ORIGINALLY REPORTED ISSUE. SUCTION OF LOT # 11512 TESTING RESULTS STATE: DURING TOOL VERIFICATION THE SUCTION TOOL TAB INTERMITTENTLY CHANGES BETWEEN GREEN AND RED. NAVIGATION IS INTERMITTENT. NEW SUCTION PROBE SENT TO THE SITE RESOLVING ISSUE.

    Description of Event or Problem · 1

    AN INDIVIDUAL FROM A SITE REPORTED THAT THE STRAIGHT SUCTION WOULD TAKE SEVERAL ATTEMPTS TO VERIFY. IT WOULD THEN TRACK INTERMITTENTLY AND BE INACCURATE. THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM AND NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT SUCTION, AXIEM¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 73673400

    Patients

    Seq Age Sex Outcome Treatment
    1