BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 3102625 · Received May 1, 2013

    Report

    Report Number
    3006697299-2013-00035
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    January 23, 2013
    Report Date
    April 30, 2013
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ORIGINALLY THIS REPORT WAS DESCRIBED AS FOLLOWS; THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE WAS CONNECTED AND STARTED FINE. DURING THE CASE, THE HANDPIECE FAILED. ON (B)(6) 2013, ADDITIONAL INFO CHANGED THIS COMPLAINT TO AN MDR. THE FOLLOWING WAS PROVIDED; THE PTS' AGE AND GENDER. THE SURGERY WAS A CRANIOTOMY AND THE UNIT FAILED TWO HOURS INTO THE PROCEDURE. THERE WAS A DELAY OF 45 MINS AND THE PTS WAS UNDER THE EFFECTS OF ANESTHESIA WHEN THE CUSA FAILED. THE SURGEON WAS ABLE TO PERFORM THE SURGERY WITH ALTERNATIVE METHODS SUCCESSFULLY. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190144 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR