BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE - POOL

    MDR report key: 2151221 · Received June 21, 2011

    Report

    Report Number
    3006697299-2011-00019
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    March 15, 2011
    Report Date
    June 21, 2011
    Manufacturer
    INTEGRA, TULLAMORE
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THERE WAS AN "E0002" SUCTION ERROR THAT WOULD NOT CLEAR. OTHER ERRORS CAME UP INTERMITTENTLY. THE UNIT CYCLED THROUGH A NUMBER OF ERROR CODES. THIS CUSA NXT WAS GOING TO BE USED ON TRIAL BY THE PHYSICIAN. ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY, AND NO DELAY IN THE SURGICAL PROCEDURE, INTEGRA LIFESCIENCES CORPORATION'S RISK MANAGEMENT REVIEW ON (B)(6) 2011, INDICATED THAT AN ERROR CODE FOR A SUCTION SYSTEM FAILURE CAN CAUSE A REDUCTION IN ANTICIPATED ASPIRATION WHICH CAN CAUSE A BUILD-UP OF DEBRIS BOTH IN THE PATIENT AND IN THE SUCTION TUBING. IT CAN ALSO CAUSE A LOSS OF ASPIRATION WHICH CAN CAUSE A DELAY IN THE SURGICAL PROCEDURE UNTIL AN ALTERNATIVE SUCTION SYSTEM IS OBTAINED. THE PATIENT'S RISK IS CLASSIFIED AS MODERATE AS THE DELAY IN PROCEDURE HAS THE POTENTIAL TO CAUSE MINOR BUT REVERSIBLE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA NXT CONSOLE - POOL ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA, TULLAMORE

    Patients

    Seq Age Sex Outcome Treatment
    1