BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 2941961 · Received December 21, 2012

    Report

    Report Number
    1811755-2012-04333
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 10, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE REP WAS SENT TO THE USER FACILITY TO EVALUATE THE DEVICE, AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE ROVER STOPPED FUNCTIONING. AS A RESULT, THE PROCEDURE WAS DELAYED BY 30 MINS. A BACKUP ROVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT OR USER INJURY REPORTED, AND NO OTHER ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE 2 ROVER ULTRA (120V) FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK