BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3072788 · Received April 23, 2013

    Report

    Report Number
    0001811755-2013-00864
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CORD ON THE ROVER IS FRAYED AND THERE ARE EXPOSED INNER WIRES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE. THE SERVICE TECHNICIAN REPLACED THE POWER CORD AND RETURNED THE UNIT TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175497 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1