BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 36KHZ MICROTIP PLUS BOX4

    MDR report key: 2122090 · Received May 24, 2011

    Report

    Report Number
    1222895-2011-00010
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    March 3, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTEGRA, BURLINGTON
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CUSA TIP WAS EXAMINED AND IT WAS DETERMINED THE TIP WAS BLOCKED WITH AN UNK SUBSTANCE. IF THE BLOCKAGE OCCURRED DURING THE PROCEDURE THE TIP WOULD OVERHEAT AND CAUSE THE TIP TO BREAK. 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

    A CUSA MICROTIP PLUS WAS INVOLVED IN AN INCIDENT AND WAS DESCRIBED AS FOLLOWS: THE SURGEON WAS TREATING A CRANIOPHARYNGIOMA (HARD TUMOR), ON A CHILD WHILE UTILIZING A CUSA MICROTIP PLUS (B)(4). THE SURGERY WAS COMPLETED WHEN THE TIP BROKE. THERE WAS NO INJURY OR DELAY IN SURGERY AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL 36KHZ MICROTIP PLUS BOX4 ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA, BURLINGTON

    Patients

    Seq Age Sex Outcome Treatment
    1