BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCEL 36KHZ MICRO TIP PLUS BOX4

    MDR report key: 1914419 · Received November 19, 2010

    Report

    Report Number
    1222895-2010-00024
    Event Type
    Other
    Date Received
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    INTEGRA
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    A CUSA MICRO EXTENDED TIP C4615S WAS BEING USED IN A TUMOR REMOVAL PROCEDURE BY USING AN ENDONASAL APPROACH. THE SURGEON NOTED THAT AFTER THE PROCEDURE THAT THE TIP HAD BURNT THE INSIDE OF THE PT'S NOSE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL 36KHZ MICRO TIP PLUS BOX4 ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1