BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE (115-230V)

    MDR report key: 1829284 · Received August 27, 2010

    Report

    Report Number
    1222895-2010-00012
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    April 26, 2010
    Report Date
    August 27, 2010
    Manufacturer
    INTEGRA RADIONICS, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NXT CONSOLE AND SERVICE MODULE WAS EVALUATED. THE UNIT WAS TURNED ON AND OPERATED WITH TWO SEPARATE 35 KHZ HAND PIECES WITH NO SYSTEM ERRORS OBSERVED. ROOT CAUSE IS INDETERMINATE AT THIS TIME AS THE ERROR OBSERVED AT THE SITE COULD NOT BE REPLICATED. ALL TESTING PERFORMED ON THE NXT UNIT INDICATES THAT THE UNIT IS IN GOOD WORKING ORDER. IT WAS NOTED THAT WHEN THE INITIAL ERROR WAS OBSERVED ON THE NXT, THE CANISTER LINER WAS CHANGED CORRECTING THE INSUFFICIENT SUCTION. ERRORS OBSERVED AT THE SITE COULD HAVE BEEN TRIGGERED BY A BAD CONNECTION ON THE CANISTER WHICH CAUSED THE UNIT TO NOT FUNCTION PROPERLY. A DHF REVIEW WAS PERFORMED AND NO INCONSISTENCIES WERE IDENTIFIED. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A LIVER RESECTION WAS BEING PERFORMED ON A PATIENT. AFTER FIFTEEN PLUS MINUTES OF ULTRASONIC USE OF THE CUSA NXT, THE SUCTION DECREASED TO 14MMHG AND HAD AN ERROR OF INSUFFICIENT SUCTION. THE SCRUB NURSE FLUSHED THE HAND PIECE MULTIPLE TIMES BUT THERE WAS NO CHANGE. THE CANISTER LINER WAS CHANGED AND THIS RESOLVED THE SUCTION PROBLEM. THE SURGEON THEN BEGAN USING THE CUSA NXT AGAIN AND HE HAD NO ULTRASONIC POWER. THERE WAS NO ALARM AT FIRST AND THEN THE POWER ALARM - CAME OFF WITH E0003 CODE. THERE WAS NO PATIENT INJURY. THE DELAY IN SURGERY WAS REPORTED AS LESS THAN ONE MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA NXT CONSOLE (115-230V) ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA RADIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK