BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 2885396 · Received December 12, 2012

    Report

    Report Number
    1811755-2012-04221
    Event Type
    Death
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE USER FACILITY HAS NOT DIRECTLY REPORTED ANY ADVERSE EVENT INFO TO STRYKER. ADDITIONALLY, STRYKER HAS NOT RECEIVED ANY DEVICE MALFUNCTION ALLEGATIONS OR REQUESTS FOR DEVICE SERVICING, AS A RESULT OF THIS EVENT. NUMEROUS VERBAL AND WRITTEN COMMUNICATION ATTEMPTS TO THE USER FACILITY WERE PERFORMED, HOWEVER ALL ATTEMPTS WERE UNANSWERED.

    Description of Event or Problem · 1

    A STRYKER SALES REP BECAME AWARE OF A PT DEATH, RESULTING FROM A MEDIASTINOSCOPY, THORACOTOMY, AND LOBECTOMY. IT IS SUSPECTED THAT A STRYKER NEPTUNE ROVER MAY HAVE BEEN USED DURING THE PROCEDURE. NO FURTHER INFO WAS AVAILABLE AND NUMEROUS ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE USER FACILITY WERE UNSUCCESSFUL.

    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 60 YR Death