BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 3020691 · Received March 18, 2013

    Report

    Report Number
    3006697299-2013-00019
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 18, 2013
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    IT WAS REPORTED THAT A CUSA EXCEL 23KHZ CEM NOSECONE WOULD NOT TURN OFF DURING A LIVER RESECTION. THE EVENT WAS DESCRIBED AS FOLLOWS: "DIATHERMAY COMPONENT ON THE HAND PIECE OF THE CUSA HAD BEEN WORKING FOR HALF AN HOUR WHEN SUDDENLY THE DIATHERMY WOULD NOT TURN OFF. THE PLUG WAS REMOVED FROM THE DIATHERMY MACHINE TO PREVENT BURNING THE PATIENT." THERE WAS NO ADVERSE EVENT TO THE PATIENT AND THERE WAS NO DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112856 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED 1121142

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR