BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE

    MDR report key: 3160095 · Received June 10, 2013

    Report

    Report Number
    0001811755-2013-01326
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN FOUND THAT THE PRECISION BALL WAS STUCK RESULTING IN THE ROVER NOT HAVING SUCTION. AFTER HE DISLODGED THE PRECISION BALL THE ROVER FUNCTIONED AS INTENDED. THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER PUSHED FLUID OUT THROUGH THE MANIFOLD DURING A CASE. THERE WAS A 30 MINUTE DELAY IN THE CASE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT OR USER INJURY AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER PUSHED FLUID OUT THROUGH THE MANIFOLD DURING A CASE. THERE WAS A 30 MINUTE DELAY IN THE CASE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT OR USER INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260266 NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1