BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 3753435 · Received February 4, 2014

    Report

    Report Number
    3006697299-2014-00008
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 10, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    THIS IS THE SECOND REPORT OF TWO THAT INVOLVED A CUSA EXCEL 36 KHZ HANDPIECE THAT WAS REPORTED TO HAVE BECOME HOT DURING BRAIN TUMOR REMOVAL. THERE WAS NO DELAY IN THE SURGERY AS A RESULT OF THIS ISSUE. NEITHER THE SURGEON NOR PT INCUR AN INJURY AS A RESULT OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73491 EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LBK INTEGRA NEUROSCIENCES, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1