BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 23KHZ STRAIGHT HANDPIECE

    MDR report key: 2852651 · Received November 27, 2012

    Report

    Report Number
    8010219-2012-00033
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO FROM THE SAME FACILITY INVOLVING AN EXCEL 23 KHZ HAND PIECE AND A 23 KHZ STANDARD TIP CROSS REFERENCE WITH MFR 2648968-2012-00046 (PR 77995). THE INITIAL INFO RECEIVED INDICATED THAT THE EXCEL 23 KHZ HAND PIECE WAS BEING TESTED AND THERE WAS NO PT CONTACT/IMPACT INFO. THE INFO RECEIVED ON (B)(4) 2012 WAS AS FOLLOWS: "THE CUSA EXCEL CONSOLE AND THE HAND PIECE THAT WERE USED AND BELIEVES THE HAND PIECE IS FAULTY. WHEN TESTING THE HAND PIECE, WITH AMPLITUDE SET AT 100, TISSUE SELECTED AT STANDARD, ONCE THE FOOT PEDAL WAS PRESSED, THE AMPLITUDE ONLY ROSE TO 10%. THE FIELD TECH TESTED AND ANOTHER HAND PIECE WITH THE SAME CONSOLE ON THE SAME SETTINGS AND AMPLITUDE ROSE TO 100%." THEN ON (B)(6) 2012, ADD'L INFO BECAME AVAILABLE AND CHANGED THIS COMPLAINT TO REPORTABLE. THE DESCRIPTION WAS AS FOLLOWS; THE SURGEON REPORTED THAT THERE WAS A SLIGHT DELAY AS THE THEATRE STAFF CHANGED THE CUSA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL 23KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1