BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCEL CONSOLE WITH FOOTSWITCH EACH1

    MDR report key: 1913631 · Received November 30, 2010

    Report

    Report Number
    3006697299-2010-00015
    Event Type
    Death
    Date Received
    November 30, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD.
    Product Code
    LFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA REPRESENTATIVES FROM THE CORPORATE COMPLAINT DEPT, (B)(4) HAD A CONFERENCE CALL TO REVIEW THIS COMPLAINT. THE HOSPITAL WILL NOT PROVIDE ANY INFO AT THIS TIME. IT WAS STATED BY INTEGRA REP IN (B)(4) THAT THE PT DID NOT DIE DURING THE USE OF THE CUSA EXCEL. THE CUSA EXCEL WAS NOT BEING USED AT THE TIME, IT HAD BEEN PUT ASIDE. IT WAS NOT ASSOCIATED WITH THE DEATH. THE HOSPITAL IS STILL USING THE CUSA EXCEL UNIT FOR OTHER SURGERIES. THE SERVICE EVAL WAS TO ENSURE THE EQUIPMENT WAS WORKING PROPERLY. AN INVESTIGATION OF THE CUSA EXCEL DEVICE WAS PERFORMED THE SECOND DAY AFTER SURGERY BY OUR BIOMEDICAL ENGINEERS TRAINED IN SERVICE AND REPAIR OF THE CUSA EXCEL PRODUCT LINE. THE INVESTIGATION CONFIRMED THAT THE PRODUCT PASSED ALL FUNCTIONAL TESTS. THIS SERVICE EVAL AND REPORT IS PART OF THIS COMPLAINT FILE. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS AT THIS POINT THAT THE DEATH WAS NOT RELATED TO THE USE OF THE CUSA EXCEL. AT THIS TIME, WE ARE CLOSING THE COMPLAINT AND REPORTING THE COMPLAINT TO FDA.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A (B)(6) CHILD WITH A LARGE BRAIN TUMOR DIED DURING AN EMERGENCY SURGERY. IT WAS REPORTED THAT THE CHILD HAD AN ANEURYSM DURING THE SURGERY, STARTED CODING (CARDIAC ARREST), BLED OUT AND DIED. AN INTEGRA CUSA ULTRASONIC ASPIRATOR WAS BEING USED DURING THE SURGERY FOR REMOVAL OF THE BRAIN TUMOR. IT WAS REPORTED THE CUSA EXCEL ULTRASONIC ASPIRATOR SEEMED TO BE MAKING EXCESSIVE NOISE, PERHAPS DUE TO TISSUE BLOCKAGE. THEY USED A STYLET TO CLEAR THE TUBING. THE CUSA WAS PLACED ASIDE DURING THE SURGERY AND WAS NOT IN USE WHEN THE CHILD HAD THE ANEURYSM AND DIED. THE HOSPITAL HAS NOT SUGGESTED THAT THE CUSA WAS ASSOCIATED WITH THE ANEURYSM AND DEATH OF THE CHILD. THE HOSPITAL WANTED TO ENSURE ALL EQUIPMENT USED DURING THE SURGERY WAS FUNCTIONING AS INTENDED. INTEGRA SENT A TRAINED BIOMEDICAL ENGINEER TO THE HOSPITAL FOR A SERVICE EVAL AND TESTING. THE SERVICE ENGINEER ISSUED A REPORT THAT STATED THE CUSA EXCEL ULTRASONIC ASPIRATOR WAS FUNCTIONING AS INTENDED.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Death