BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3932788 · Received July 14, 2014

    Report

    Report Number
    0001811755-2014-02506
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOSS OF FUNCTION OF THE SMOKE EVACUATOR WAS CONFIRMED BY A MANUFACTURER FIELD REPAIR TECHNICIAN THROUGH VISUAL INSPECTION. UPON DISASSEMBLY, IT WAS FOUND THAT THE SMOKE EVACUATOR MOTOR WAS IN NEED OF REPLACEMENT, WHICH CAN CAUSE THE REPORTED EVENT. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE BY A MANUFACTURER FIELD REPAIR TECHNICIAN AT THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS NOT EVACUATING SMOKE DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS NOT EVACUATING SMOKE DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409468 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1