BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL CONSOLE WITH FOOTSWITCH EACH1

    MDR report key: 1860016 · Received September 17, 2010

    Report

    Report Number
    3006697299-2010-00007
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    A CUSA EXCEL CONSOLE WORKED INTERMITTENTLY DURING A PRE-TEST BEFORE AN HEPATECTOMY. THE UNIT WAS IN CONTACT WITH THE PATIENT, THERE WAS NO INJURY INVOLVED WITH THIS REPORT AND THE EVENT DID NOT INCREASE THE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL CONSOLE WITH FOOTSWITCH EACH1 ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LTD. HGE1000702IE

    Patients

    Seq Age Sex Outcome Treatment
    1