BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA XCEL 23KHZ CEM NODECONE

    MDR report key: 3070568 · Received April 17, 2013

    Report

    Report Number
    3006697299-2013-00029
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 INFORMATION.

    Description of Event or Problem · 1

    CASE #8 FROM THE SAME DISTRIBUTOR INVOLVED IN A CUSA EXCEL 23KHZ CEM NOSECONE (LOT # 1115499) THAT ACTIVATED AFTER ONE HOUR OF USE EVEN THOUGH THE BUTTON FOR ACTIVATING THE UNIT HAD NOT BEEN PRESSED. THE UNIT COULD NOT BE DEACTIVATED. THE SETTING WAS 60 - 70% POWER DURING A LIVER RESECTION. THERE WAS NO INJURY REPORTED. THERE WAS NO DELAY AS THE STAFF WAS ABLE TO USE ANOTHER UNIT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165634 CUSA XCEL 23KHZ CEM NODECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED 1115499

    Patients

    Seq Age Sex Outcome Treatment
    1