BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE

    MDR report key: 6129419 · Received November 28, 2016

    Report

    Report Number
    0008043928-2016-00058
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 2, 2016
    Report Date
    February 14, 2017
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP BEING SUBMITTED FOR INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE IRRIGATION WAS NOT FUNCTIONING PROPERLY. A LACK OF IRRIGATION IN THE DEVICE IS KNOWN TO CAUSE OVERHEATING. THE USER FACILITY REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY AND THAT THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE IRRIGATION WAS NOT FUNCTIONING PROPERLY. A LACK OF IRRIGATION IN THE DEVICE IS KNOWN TO CAUSE OVERHEATING. THE USER FACILITY REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY AND THAT THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780392 SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1