BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STRAIGHT HANDPIECE

    MDR report key: 3912435 · Received May 14, 2014

    Report

    Report Number
    3006697299-2014-00037
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Report Date
    April 17, 2014
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PRODUCT HAS A CRACKED HOUSING AND THERE WAS A COOLING ALARM ON START UP. THERE WAS NO PATIENT CONTACT BECAUSE THE PRODUCT WOULD NOT PASS THE INITIAL SETUP TESTS ON THE CUSA CONSOLE. THERE WAS NO PATIENT INJURY. THE PRODUCT PROBLEM DID NOT DELAY SURGERY START BUT IT POTENTIALLY LENGTHENED THE SURGERY TIME DUE TO THE SET UP TIME OF CHANGING HANDPIECES AND THE ALTERNATE AVAILABLE HANDPIECE NOT BEING AS POWERFUL. AS PER SALES REPRESENTATIVE, THE PRODUCT DID NOT APPEAR OVERTORQUED. VISUALLY, THE ASPIRATION HOLE AND DOT ON THE HANDPIECE WERE ALIGNED PROPERLY. IT WAS REPORTED THAT THE SALES REPRESENTATIVE CHECKED THE STERILIZATION PARAMETERS FROM THE CYCLE AS WELL AND IT WAS STANDARD STEAM STERILIZATION AS ALWAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288142 CUSA EXCEL 23KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1