BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2425126 · Received January 17, 2012

    Report

    Report Number
    1811755-2012-00202
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVALUATION CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN, EXPOSED WIRING ON THE POWER CORD WAS OBSERVED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT 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
    1 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK