BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 2924809 · Received January 22, 2013

    Report

    Report Number
    0001811755-2013-00027
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE TECHNICIAN WAS SENT TO THE USER FACILITY TO EVALUATE THE DEVICE. THE REPORTED ISSUE COULD NOT BE REPLICATED AND NO OTHER ASSOCIATED PROBLEMS WERE FOUND. THE ROVER WAS FUNCTIONALLY TESTED AND RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE ROVER WOULD NOT ACCEPT A MANIFOLD ACCESSORY. AS A RESULT, THE PROCEDURE WAS DELAYED TWO HOURS. NO PATIENT 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
    31154 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MANIFOLD