BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 1860258 · Received September 22, 2010

    Report

    Report Number
    1811755-2010-01228
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECHNICIAN AND IT WAS DETERMINED THAT THE SCREWS ON THE POWER PLUG WERE LOOSE CAUSING THE EVENT. THE PLUG WAS REPAIRED AND TESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER'S POWERCORD SPARKED WHILE IT WAS BEING UNPLUGGED AFTER A PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK