BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3801236 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02885
    Event Type
    Other
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. THE FSE TESTED THE ECM ARM CANNULA MOUNT USING ONE OF THE SITE'S CANNULAS AND THE TABS ON THE ECM CANNULA MOUNT ARM OPENED AND CLOSED WITHOUT ANY ISSUES NOTED. THE CANNULA MOUNT HOLDS THE CANNULAS SECURELY IN PLACE. DURING THE FSE'S INVESTIGATION, HE MET WITH THE OPERATING ROOM (OR) NURSES. ACCORDING TO THE FSE, THE OR NURSES PROVIDED HIM WITH 3 DIFFERENT SCENARIOS THAT OCCURRED. IT WAS UNCLEAR TO THE FSE ABOUT WHEN THE TABS ON THE ECM ARM CANNULA MOUNT FAILED IN RELATION TO INSTALLATION OF THE CANNULA OR CAMERA. THE NURSES TOLD THE FSE THAT ONE OF THE FOLLOWING SCENARIOS OCCURRED: *THE WINGS ON THE ECM ARM CANNULA MOUNT WOULD NOT STAY CLOSED AFTER THE CANNULA WAS INSTALLED. THE WINGS ON THE ECM ARM CANNULA MOUNT WOULD NOT OPEN TO ALLOW FOR INSTALLATION OF THE CAMERA ONTO THE ECM ARM. *THE WINGS ON THE ECM ARM CANNULA MOUNT WOULD NOT STAY CLOSED AFTER THE CAMERA WAS INSTALLED ONTO THE ECM ARM. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE SITE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER THE TABS ON THE ECM ARM CANNULA MOUNT WOULD NOT OPEN OR CLOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE WINGS ON THE ENDOSCOPIC CAMERA MANIPULATOR'S (ECM) ARM CANNULA MOUNT WOULD NOT OPEN. AS A RESULT, THE SITE WAS UNABLE TO ADVANCE THE CAMERA. PRIOR TO CONTACTING INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ASSISTANCE, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGICAL PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278727 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other