BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 2442200 · Received January 30, 2012

    Report

    Report Number
    1811755-2012-00347
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    October 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT REQUEST REPAIR SERVICES FORM STRYKER FOR THE ROVER UNIT. THE DEVICE REMAINS IN CIRCULATION AT THE USER FACILITY. THE USER FACILITY DID NOT REQUEST REPAIR SERVICES FROM STRYKER, SO THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION. THERE WERE NO ALLEGATIONS THAT THE ROVER MALFUNCTIONED OR DID NOT PERFORM ITS INTENDED USE. THE NEPTUNE ROVER INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING SAFETY WARNING "THE HEALTH CARE PROFESSIONAL PERFORMING ANY PROCEDURE IS RESPONSIBLE FOR DETERMINING THE APPROPRIATENESS OF THIS EQUIPMENT AND THE SPECIFIC TECHNIQUE USED FOR EACH PT. STRYKER, AS A MANUFACTURER, DOES NOT RECOMMEND SURGICAL PROCEDURE OR TECHNIQUE." A REVIEW OF COMPLAINT RECORDS FOR THIS MODEL NUMBER, REVEALED NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CARDIAC SURGERY, THE ROVER WAS BEING USED TO COLLECT SURGICAL WASTE. AFTER OPENING THE CHEST CAVITY WITH A STERNUM SAW, EXCESSIVE BLEEDING WAS OBSERVED BY THE SURGICAL TEAM. IT WAS DISCOVERED THAT A SMALL PORTION OF TISSUE WAS MISSING FORM THE PT'S LEFT VENTRICLE. IT WAS THEN OBSERVED THAT A TISSUE FRAGMENT WAS PRESENT ON THE SUCTION TUBING CONNECTED TO THE ROVER. THE INJURY WAS CLAMPED AND SUTURED, WHICH SUCCESSFULLY STOPPED THE BLEEDING. IT WAS REPORTED THAT THE PT LOST APPROXIMATELY 250MLS OF BLOOD. THE PT DID NOT REQUIRE A BLOOD TRANSFUSION OR ANY OTHER ADDITIONAL MEDICAL INTERVENTION. ALTERNATIVE SUCTION WAS USED TO SUCCESSFULLY COMPLETE THE REMAINDER OF THE PROCEDURE.

    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 Required Intervention