BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CUSA EXCEL

    MDR report key: 2899690 · Received January 2, 2013

    Report

    Report Number
    3006697299-2012-00052
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 2, 2013
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A "DEFAULT" WAS REPORTED WITH A CUSA EXCEL CONSOLE WHICH WAS SMOKING/SMELL OF SMOKE COMING FROM THE CONSOLE. THE FOOTSWITCH PLUG IS ALSO DAMAGED. THE UNIT WAS IN CONTACT WITH A PATIENT HOWEVER, THERE WAS NO INJURY INVOLVED AND THERE WAS NO SURGICAL DELAY AS A RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317 UNKNOWN CUSA EXCEL ULTRASONIC SURGICAL PRODUCTS LBK INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1