BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2482298 · Received March 2, 2012

    Report

    Report Number
    1811755-2012-00732
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    November 9, 2011
    Report Date
    December 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION DISCOVERED A CUT IN THE POWER CORD, WHICH EXPOSED BARE WIRES. THE CAUSE OF THE CORD DAMAGE IS UNK, BUT MAY BE THE RESULT OF MISHANDLING. THE MFR SERVICE TECH INSTALLED A NEW POWER PLUG AT THE POINT WHERE THE POWER CORD AS CUT. THE ROVER WAS FUNCTIONALLY TESTED AND RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVAL CONDUCTED BY A MFR FIELD SERVICE TECH, EXPOSED BARE WIRES WERE OBSERVED FROM A CUT IN THE ROVER POWER CORD. 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