BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3072785 · Received April 23, 2013

    Report

    Report Number
    0001811755-2013-00867
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN WAS NOT ABLE TO CONFIRM THE REPORTED EVENT THAT THE ROVER HAD A DEFECTIVE PLUG AND EXPOSED WIRES. THE TECHNICIAN DID FIND THAT THE UNIT HAD A HUBBLE LOCK PLUG WHICH IS NOT A STRYKER PROVIDED PLUG. BASED ON THE IFU, THE CUSTOMER SHOULD NOT MODIFY THE STRYKER PROVIDE PLUG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER'S POWER CORD HAS EXPOSED WIRING. THIS WAS NOTICED PRIOR TO A PROCEDURE DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER'S POWER CORD HAS EXPOSED WIRING. THIS WAS NOTICED PRIOR TO A PROCEDURE DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175506 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1