BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3804684 · Received May 12, 2014

    Report

    Report Number
    0001811755-2014-01709
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3 OTHER TEXT : FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN WAS NOT ABLE TO CONFIRM THE REPORTED EVENT AS THE DEVICE WAS NOT MADE AVAILABLE FOR HIM TO EVALUATE WHEN HE WAS AT THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS NOT OFFLOADING AT THE USER FACILITY, RESULTING IN A 30 MINUTE TO 1 HOUR DELAY. HOW THE ISSUE WAS NOTICED, MEDICAL INTERVENTION AND ADVERSE CONSEQUENCES ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE WAS NOT OFFLOADING AT THE USER FACILITY, RESULTING IN A 30 MINUTE TO 1 HOUR DELAY. HOW THE ISSUE WAS NOTICED, MEDICAL INTERVENTION AND ADVERSE CONSEQUENCES ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284073 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1