BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE

    MDR report key: 2902191 · Received January 8, 2013

    Report

    Report Number
    0001811755-2013-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER FIELD SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVALUATION CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN, THERMAL DAMAGE TO THE PLASTIC POWER PLUG HOUSING WAS OBSERVED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9148 NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1