BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2507103 · Received March 23, 2012

    Report

    Report Number
    1811755-2012-01098
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR FIELD SERVICE TECH WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE. VISUAL INSPECTION CONFIRMED THAT A WIRE FROM THE POWER CORD HAD DISCONNECTED FROM THE POWER PLUG ASSEMBLY. THE CAUSE OF THE DAMAGE IS UNK, BUT MAY BE THE RESULT OF MISHANDLING WHEN THE UNIT IS UNPLUGGED FROM THE WALL OUTLET. THE UNIT WAS REPAIRED AND RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVAL CONDUCTED BY A MFR FIELD SERVICE TECH, EXPOSED BARE WIRES WERE OBSERVED WHERE THE POWER CORD CONNECTS TO THE POWER PLUG. NO PT INVOLVEMENT, USER INJURY, OR ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK