BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2519301 · Received March 30, 2012

    Report

    Report Number
    1811755-2012-01167
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 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 SVC TECH WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE, HOWEVER, WAS UNABLE TO REPLICATE THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE ROVER'S SMOKE EVACUATOR STOPPED FUNCTIONING. THE SURGICAL TEAM RESTARTED THE UNIT AND COMPLETED THE PROCEDURE WITH THIS SAME EQUIPMENT. THERE WAS NO REPORT OF ANY PT OR USER EXPOSURE TO SURGICAL PLUME. 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