BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1003519 · Received February 19, 2008

    Report

    Report Number
    2955842-2008-00071
    Event Type
    Other
    Date Received
    February 19, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 19, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING FOUND THE SYSTEM TO PERFORM TO ISI STANDARDS. PERFORMANCE TESTING WAS CONDUCTED AND THE REPORTED COMPLAINT COULD NOT BE REPLICATED. AS OF FEBRUARY 19, 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE SITE EXPERIENCED DIFFICULTIES REMOVING THE INSTRUMENT FROM A PT SIDE MANIPULATOR. THE INSTRUMENT WAS INSERTED ABOUT TWO INCHES PAST THE CANNULA TIP BUT WAS NOT RESPONDING TO THE SURGEON'S COMMANDS. THE MESSAGE ON THE SCREEN INDICATED THE INSTRUMENT WAS NOT PAST THE CANNULA TIP. THE SURGICAL STAFF WAS UNABLE TO PHYSICALLY REMOVE THE INSTRUMENT AS THE INSTRUMENT TIP WAS FULLY OPEN AND COULD NOT PASS THROUGH THE CANNULA. USING A LAPAROSCOPIC TOOL VIA THE ACCESSORY PORT, THE SITE WAS ABLE TO CLOSE THE INSTRUMENT TIP ENOUGH TO ALLOW IT TO PASS THROUGH THE CANNULA. AN ISI REGIONAL SUPPORT SPECIALIST ATTEMPTED TO TROUBLESHOOT THE ISSUE VIA TELEPHONE AND REQUESTED THAT THE SITE REPLACE THE STERILE ADAPTER. THE SITE ADVISED THAT THEY WOULD CONVERT TO OPEN TECHNIQUES TO FINISH THE PLANNED SURGERY. THE PT HAD BEEN UNDER ANESTHESIA FOR 3.5 HOURS. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4. 3P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DA VINCI SURGICAL SYSTEM INSTRUMENTS