BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3844638 · Received June 3, 2014

    Report

    Report Number
    0001811755-2014-02020
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT FLAG THE DEVICE FOR REPAIR BECAUSE THEY DID NOT BELIEVE THE UNIT MALFUNCTIONED. THE DEVICE IS THEREFORE UNAVAILABLE FOR ROOT CAUSE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS CONNECTED TO THE PATIENT'S ORAL GASTRIC TUBE AT THE END OF AN ENTEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS DISCHARGED AS STABLE. OVERNIGHT, THE PATIENT DEVELOPED SOME GI BLEEDING AND WAS TRANSFERRED BACK TO THE USER FACILITY FOR TREATMENT, THEN DISCHARGED AGAIN. ACCORDING TO THE CUSTOMER, THE PATIENT IS FRAGILE AND HAS A HISTORY OF GI BLEEDING PROBLEMS, MULTI-SYSTEM ISSUES AND ANATOMICAL MALFORMATIONS. THE CUSTOMER DOES NOT BELIEVE THERE WAS CAUSE AND EFFECT BETWEEN THE NEPTUNE USE AND THE GI BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324674 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R