BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE (115-230V)

    MDR report key: 1880970 · Received October 5, 2010

    Report

    Report Number
    1222895-2010-00016
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 5, 2010
    Manufacturer
    INTEGRA RADIONICS, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE CUSANXT CONSOLE HAD NOT BEEN WORKING RIGHT. THE CUSTOMER HAS TRIED THE 24 MICRO HANDPIECE AND THEY DO NOT GET MISTING. THEY HAVE ALSO TRIED THE 24 NEURO SHORT HANDPIECE AND THEY GET TOO MUCH IRRIGATION. THE PROCEDURE WAS FOR A CRANIOTOMY FOR A TUMOR REMOVAL ON A (B)(6) MALE PATIENT. THE PRODUCT PROBLEM DID CAUSE A DELAY IN SURGERY. IT WAS REPORTED IT PROBABLY ADDED AN HOUR ONTO THE CASE. THERE WAS NO HARM TO THE PATIENT. THE TUMOR WAS REMOVED.

    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 19 YR