BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2465436 · Received February 16, 2012

    Report

    Report Number
    1811755-2012-00516
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 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 AT THE END OF A SURGICAL PROCEDURE, AN EXPOSED WIRE FROM THE ROVER POWER CORD WAS OBSERVED NEAR THE POWER PLUG ASSEMBLY. NO PT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED 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