BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOR 24KHZ MICRO STERILE TIP & FLUE SET X 5

    MDR report key: 1557300 · Received November 30, 2009

    Report

    Report Number
    8010219-2009-00004
    Event Type
    Malfunction
    Date Received
    November 30, 2009
    Date of Event
    May 29, 2009
    Report Date
    November 30, 2009
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED INITIALLY ON MFR'S REPORT NUMBER 1222895-2009-00006. IT WAS DATED JULY 17, 2009. (B)(4). NO PRODUCT RETURNED FOR INVESTIGATION. NO ROOT CAUSE COULD BE DETERMINED. INTEGRA CONSIDERS THAT NO CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE FLUE MELTED ON THE TIP DURING A PROCEDURE WHEN THE SURGEON WAS ABLATING TISSUE. THIS STOPPED THE TIP FROM VIBRATING. INTEGRA REQUESTED ADD'L CLINICAL INFO FROM THE USER IN WRITING. NO ADD'L INFO WAS PROVIDED. THE INTEGRA REPORTER STATED THAT THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOR 24KHZ MICRO STERILE TIP & FLUE SET X 5 NA GEI INTEGRA NEUROSCIENCES, LTD. 030633

    Patients

    Seq Age Sex Outcome Treatment
    1