BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 3977659 · Received August 4, 2014

    Report

    Report Number
    0001811755-2014-02779
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SMOKING OF THE DEVICE WAS NOT ABLE TO BE CONFIRMED BY A MANUFACTURER FIELD REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. NO COMPONENTS WERE IDENTIFIED WHICH WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE AT THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE AT THE USER FACILITY ,THE DEVICE WAS SMOKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS SMOKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454275 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1