BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 1851031 · Received September 27, 2010

    Report

    Report Number
    1811755-2010-01255
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECHNICIAN AND THE ROOT CAUSE WAS FOUND TO BE A POWERCORD THAT HAD BEEN WORN OVER TIME. THE CORD WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE THE ROVER WAS UNPLUGGED IT SPARKED. THERE WAS ANOTHER UNIT IN THE ROOM SO THERE WAS NO DELAY IN THE CASE.

    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