BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSA NXT EXTENDED LENGTH TIP, 5 PACK

    MDR report key: 4028082 · Received August 6, 2014

    Report

    Report Number
    1222895-2014-00016
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    September 23, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA INC.
    Product Code
    LFL
    PMA / PMN Number
    K102258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THERE WAS EXCESSIVE HEATING OF HE 35KHZ EXTENDED TIP (1523243) WORKING ON ITS 35KHZ NEURO HANDPIECE (1523000M9) DURING A TRANSNASAL SURGERY. DURING THE OPERATION, THE SURGEON'S ASSISTANT CALLED THE DISTRIBUTOR. THE TIP WAS NOT TOUCHING THE ENDOSCOPE. THE USER WAS NOT USING A WORKING CHANNEL AND THEY WERE CAREFUL ABOUT THE TIP AND THE ENDOSCOPE. BOTH OF THEM NEVER TOUCHED EACH OTHER. THE DISTRIBUTOR ASKED ABOUT THE POSSIBILITY OF INSUFFICIENT IRRIGATION OR THE FLUE MAY HAVE BEEN BLOCKED. THE USER RESPONDED NO. THEY HAD RAISED THE IRRIGATION LEVEL TO 100 TO REDUCE HEAT AND THEY WERE CAREFUL ABOUT THE FLUE. THE TIP TEMPERATURE WAS NO HIGH THAT THE NASAL TISSUE OF THE PATIENT WAS DAMAGED. THE HANDPIECE WAS AND STILL WORKING PERFECTLY WITH ITS STANDARD TIP (1523231). THERE IS NO HEATING WITH THE STANDARD TIP. HEATING ONLY OCCURRED WITH THE EXTENDED ONE. SEVERAL ATTEMPTS WERE MADE REQUESTING ADDITIONAL INFORMATION BUT TO DATE, NO NEW INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459355 CUSA NXT EXTENDED LENGTH TIP, 5 PACK ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA BURLINGTON, MA INC. 232366

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other