BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL CONSOLE WITH FOOTSWITCH EACH1

    MDR report key: 2152406 · Received June 22, 2011

    Report

    Report Number
    3006697299-2011-00015
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 22, 2011
    Manufacturer
    INTEGRA, TULLAMORE
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 ON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CRANIOTOMY WAS BEING PERFORMED ON AN ELDERLY PT FOR TUMOR REMOVAL. AFTER THE SURGERY WAS COMPLETED, AND WHILE THE PT WAS STILL UNDER THE EFFECTS OF ANESTHESIA, THE SURGEON REQUESTED THE USE OF THE CUSA AGAIN TO "TOUCH THINGS UP." THE COOLING ALARM ALERT SOUNDED. THE UNIT DID NOT COME IN CONTACT WITH THE PT WHEN THIS OCCURRED AND THERE WAS NO INJURY INVOLVED WITH THIS REPORT. THE SURGEON DECIDED NOT TO DO ANYTHING FURTHER AS THE SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL CONSOLE WITH FOOTSWITCH EACH1 ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA, TULLAMORE

    Patients

    Seq Age Sex Outcome Treatment
    1