BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3833146 · Received May 27, 2014

    Report

    Report Number
    0001811755-2014-01948
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED EVENT THAT THE SMOKE EVACUATOR WAS NOT WORKING. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE SMOKE EVACUATOR MOTOR. A FAILURE OF THE MOTOR CONTROL ELECTRONICS CAN RESULT IN THE SMOKE EVACUATOR NOT FUNCTIONING. THE TECHNICIAN REPLACED THE SMOKE EVACUATOR MOTOR AT THE CUSTOMER SITE AND THE ROVER FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMOKE EVACUATOR OF THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS SHUTTING DOWN INTERMITTENTLY DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT 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 SMOKE EVACUATOR OF THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS SHUTTING DOWN INTERMITTENTLY DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT 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
    311677 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1