BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3790556 · Received May 5, 2014

    Report

    Report Number
    0001811755-2014-01608
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE POWER CORD DAMAGE. THE CORD WAS COMING OUT OF THE PLUG BECAUSE THE PLUG WAS DAMAGED. THE DEVICE WAS REPAIRED AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CORD OF THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS BROKEN WITH EXPOSED WIRES AND PARTIALLY MELTED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CORD OF THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS BROKEN WITH EXPOSED WIRES AND PARTIALLY MELTED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268886 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1