BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 1924809 · Received December 10, 2010

    Report

    Report Number
    1811755-2010-01993
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECH AND THE EVENT WAS CONFIRMED. THE WIRES WITHIN THE CONNECTOR WERE WORN OFF. THE WIRES WERE REPAIRED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRICAL PLUG SPARKS WHEN PLUGGING AND UNPLUGGING UNIT. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    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