BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA, 8MM, REGULAR, IS2000

    MDR report key: 909224 · Received September 4, 2007

    Report

    Report Number
    2955842-2007-00304
    Event Type
    Malfunction
    Date Received
    September 4, 2007
    Report Date
    September 4, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULA ACCESSORY WAS EVALUATED. ENGINEERING INSPECTION OF THE CANNULA FOUND THE INNER DIAMETER TO HAVE A CONSISTENT CYLINDRICAL PATTERN OF SCRATCHING/MACHINING MARKS AT THE TIP. THE SURFACE FINISH APPEARS ROUGH AS A RESULT AND MARKS MAY HAVE HIGH SPOTS THAT HAVE THE POTENTIAL TO DAMAGE INSTRUMENT SHAFTS IN CERTAIN LOADING CONDITIONS. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    THE CANNULA ACCESSORY WAS RETURNED AS PART OF AN INVESTIGATION RELATED TO AN INSTRUMENT RETURNED FROM THIS SITE WITH CANNULA RELATED TUBE ABRASIONS. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE FOLLOWING MEDWATCH REPORTS LISTED BELOW WERE ALSO SENT TO THE FDA. THESE REPORTS ONLY PERTAIN TO THE INSTRUMENTS AND CANNULA RETURNED FROM THIS SPECIFIC SITE: 2955842-2007-000300, 2955842-2007-000301, 2955842-2007-000302, 2955842-2007-3003, 2955842-2007-305, 2955842-2007-306, 2955842-2007-307, 2955842-2007-308, 2955842-2007-309, 2955842-2007-310, 2955842-2007-000311.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULA, 8MM, REGULAR, IS2000 ENDOSCOPIC ACCESSORY GCJ INTUITIVE SURGICAL, INC. 420002-02 SA071501B

    Patients

    Seq Age Sex Outcome Treatment
    1 YR DA VINCI S SURGICAL SYSTEM| INSTRUMENTS| AN ELECTROSURGICAL UNIT