BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA, 8MM, REGULAR, IS2000

    MDR report key: 2939697 · Received September 4, 2007

    Report

    Report Number
    2955842-2007-00301
    Event Type
    Malfunction
    Date Received
    September 4, 2007
    Report Date
    September 4, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    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 IT TO BE BENT AT THE DISTAL TIP. THE INNER DIAMETER HAS 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 AN INSTRUMENT RETURNED AT 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 CANNULAE RETURNED FROM THIS SPECIFIC SITE: 2955842-2007-000300, 000302, 000303, 000304, 000305, 000306, 000307, 000308, 000309 AND 000310.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULA, 8MM, REGULAR, IS2000 ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL, INC. 420002-02 SA071502A

    Patients

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