BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3192478 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01480
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    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 MANUFACTURER SERVICE TECHNICIAN REPAIRED THE POWER CORD AND RETURNED THE UNIT TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER HAD A FRAYED POWER CORD. WHEN THE FIELD SERVICE TECHNICIAN EVALUATED THE UNIT HE REPORTED THAT THE PLUG WAS LOOSE AND HAD EXPOSED INNER WIRING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294841 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1