BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3276701 · Received August 9, 2013

    Report

    Report Number
    2955842-2013-02997
    Event Type
    Other
    Date Received
    August 9, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FSE REPAIRED THE SYSTEM BY REPLACING THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM. THE ECM PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. THE ECM HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ECM IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES DUE TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM.

    Additional Manufacturer Narrative · 1

    THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE AXIS 4 CABLE WAS DE-COUPLED FROM THE HOLDING SLOTS. THE BALLS AT BOTH ENDS OF THE CABLE WERE ATTACHED; HOWEVER, THEY WERE HANGING OUT. FUNCTIONAL TESTING OF THE ECM COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE AXIS 4 CABLE. THE AXIS 4 CABLE WAS REPLACED TO REPAIR THE ECM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED ISSUES WITH THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM. THE SITE CONTACTED THEIR DISTRIBUTOR FOR TROUBLE SHOOTING ASSISTANCE. THE DISTRIBUTOR REPRESENTATIVE ARRIVED ON SITE AND FOUND THAT THE CABLES CONNECTING THE CAMERA ROLL MOTOR WITH THE CAMERA MOUNT ON THE ECM WERE BROKEN. THE SITE ATTEMPTED TO PROCEED WITH THE PROCEDURE WITH THE ECM IN ITS BROKEN STATE; HOWEVER, EVERYTIME THE SURGEON MANIPULATED THE ECM FROM THE MASTER TOOL MANIPULATORS (MTMS) ON THE SURGEON SIDE CART, THE ECM ARM ROLLED A BIT, BUT THE MOVEMENT WAS NON-INTUITIVE. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378387 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES