BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 1658750 · Received April 6, 2010

    Report

    Report Number
    1811755-2010-00339
    Event Type
    Death
    Date Received
    April 6, 2010
    Date of Event
    February 1, 2009
    Report Date
    March 12, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON INVOLVED IN THIS INCIDENT WILL BE DEPOSED, AND MORE INFO SURROUNDING THIS EVENT WILL BE AVAILABLE THEN. THE SERIAL NUMBERS FOR THE DEVICES USED IN THIS PROCEDURE ARE UNK. REPAIR RECORDS SHOW 4 DEVICES THAT WERE SERVICED AROUND THE TIME OF THE EVENT, WITH TWO BEING TURNED IN FOR NOT HAVING SUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B) (6) 2009, DURING A LAPAROSCOPIC HERNIA SURGERY, THE SUCTION OF 3 NEPTUNE ROVERS FAILED TO FUNCTION WHEN A VESSEL WAS SEVERED. THE (B) (6) PT DIED OF ANEMIA ON (B) (6) 2009. NO OTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING ROOM FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death