BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 3915270 · Received May 27, 2014

    Report

    Report Number
    3006697299-2014-00043
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 6, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC LIVER RESECTION THE CEM 23KHZ NOSECONE WAS ACTIVATED CONTINUOUSLY WITHOUT PRESSING THE BUTTON. THE HAND PIECE SETTINGS WERE STANDARD TISSUE SELECT, 70% AMPLITUDE, 3 CC/MIN IRRIGATION, 100% ASPIRATION CAUTERY MACHINE SETTINGS 70 COAG/SPRAY. IT WAS REPORTED THAT AFTER APPROXIMATELY 20 MINUTES ACTIVATION TIME THE EVENT OCCURRED. THE UNIT WAS REPLACED WITH A NEW NOSECONE. THE SURGERY WAS DELAYED APPROXIMATELY 2 MINUTES. THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311124 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED 1132326

    Patients

    Seq Age Sex Outcome Treatment
    1