BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 4110331 · Received September 23, 2014

    Report

    Report Number
    0001811755-2014-03339
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE VACUUM GAUGE NOT WORKING WAS CONFIRMED BY A MANUFACTURER FIELD SERVICE TECHNICIAN. POTENTIAL CAUSES FOR THE REPORTED EVENT INCLUDE A COMPONENT FAILURE. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE BY A MANUFACTURER FIELD SERVICE REPRESENTATIVE AT THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE VACUUM GAUGE OF THE ROVER DID NOT WORK, A CONDITION IN WHICH THE ROVER CAN APPLY A HIGHER LEVEL OF SUCTION THAN INTENDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591706 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1