BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOR 24 KHZ MICRO HANDPIECE

    MDR report key: 1886353 · Received October 18, 2010

    Report

    Report Number
    8010219-2010-00011
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 18, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SELECTOR 24 KHZ MICRO HANDPIECE WAS USED DURING A CRANIOTOMY FOR TUMOR REMOVAL. IT WAS REPORTED THAT THE PRODUCT DID NOT PROVIDE ANY MISTING. THIS HANDPIECE WAS USED ALONG WITH THE CUSA NXT CONSOLE AND SERVICE MODULE (MFR REPORT NUMBERS 1222895-2010-00016 AND 1222895-2010-00017). THERE WAS A DELAY IN SURGERY OF ONE HOUR. THERE WAS NO HARM TO THE PATIENT. THE TUMOR WAS REMOVED. CROSSED REFERENCED TO MANUFACTURER REPORT NUMBER 8010219-2010-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOR 24 KHZ MICRO HANDPIECE N/A LFL INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR