BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 2477645 · Received February 28, 2012

    Report

    Report Number
    1811755-2012-00675
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR FIELD SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE ROVER. THE DEVICE INSPECTION CONFIRMED THE CUSTOMER'S COMPLAINT AND THE MANIFOLD RECEPTACLE ASSEMBLY WAS REPLACED. 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 IN THE MANIFOLD PORT. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A 30 MIN DELAY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PT AS A RESULT OF THE SURGICAL DELAY. NO PT OR USER INJURY WAS REPORTED, AN NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE 2 ROVER ULTRA (120V) FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK