BEUDAMED
    FDA Adverse Event Other Summary report: N

    WAYPOINT NAVIGATOR

    MDR report key: 2677628 · Received July 26, 2012

    Report

    Report Number
    3005677147-2012-00005
    Event Type
    Other
    Date Received
    July 26, 2012
    Date of Event
    July 3, 2012
    Report Date
    July 3, 2012
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ANCHOR SCANS AND EVAL OF THE WAYPOINT NAVIGATOR BY THE PROCEDURAL SUPPORT SPECIALIST, IT WAS NOTED THAT THE CT SCANNER USED BY THE HOSPITAL PREVIOUSLY WAS FAULTY AND SHOWING ANCHOR VISUALIZATION ISSUES. THE SURGERY FOR THE SECOND SIDE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PT IMPACT. THE WAYPOINT NAVIGATOR SYSTEM DID NOT SHOW ANY ISSUES AND PERFORMED AS REQUIRED.

    Description of Event or Problem · 1

    USER REPORTED TO FHC TECHNICAL SUPPORT SPECIALIST AN ISSUE WITH PLANNING A BILATERAL PLATFORM SURGERY USING THE WAYPOINT NAVIGATOR. DURING THE PLANNING PROCEDURE IT WAS OBSERVED THAT ONE OF THE 4 ANCHORS WAS BLURRY AND GAVE A MIRRORED OR DOUBLED EFFECT, THUS MAKING IT DIFFICULT TO SELECT THE ANCHOR DURING PLANNING. PLANNING WAS COMPLETED AND THE USER WAS MADE AWARE THAT THE FIT OF THE PLATFORM WOULD BE COMPROMISED, BUT THE USER WAS CONFIDENT ABOUT MOVING AHEAD WITH 3 PLATFORM FEET ATTACHED IF IT WAS NECESSARY. THE SURGERY FOR ONE SIDE WAS COMPLETED SUCCESSFULLY. THE SURGEON DECIDED TO RESCAN AND REPLAN THE SECOND SIDE. THE SAME CT SCANNER WAS USED TO PERFORM THE SCANS AND THE ANCHORS WERE FOUND TO BE BLURRY ONCE AGAIN. THE HOSPITAL REP THEN DECIDED TO SWITCH THE SCANNER FROM THE PHILLIPS SCANNER TO THE GE SCANNER. THE ANCHOR SCANS FROM THE GE SCANNER CAME OUT PERFECT WITH NO ANCHOR VISUALIZATION ISSUES. THERE WAS NO EVIDENCE THAT THE PT WAS HARMED WITH THE WAYPOINT NAVIGATOR OR THE CT SCANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAYPOINT NAVIGATOR WAYPOINT NAVIGATOR HAW FHC, INC. 66-WP-PL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK