BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2507104 · Received March 23, 2012

    Report

    Report Number
    1811755-2012-01100
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE TECHNICIAN CONFIRMED THAT THE SMOKE EVACUATOR DID NOT SUCTION DUE TO A NON-FUNCTIONING SMOKE MOTOR. THE MOTOR WAS REPLACED AND THE ROVER WAS RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE ROVER'S SMOKE EVACUATOR HAD NO SUCTION. THE PROCEDURE WAS COMPLETED USING THIS SAME EQUIPMENT, WITHOUT CAUSING A DELAY. 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