BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3530736 · Received December 20, 2013

    Report

    Report Number
    2955842-2013-05866
    Event Type
    Other
    Date Received
    December 20, 2013
    Date of Event
    November 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISI FIELD SERVICE ENGINEER THAT PERFORMED THE ON SITE EVALUATION OF THE SYSTEM WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED ISSUE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE PROCEDURE ON (B)(6) 2013. IT WAS NOTED THAT THERE WAS AN ERROR CODE 23030 FOR RIGHT MASTER TOOL MANIPULATOR(MTM).THE ERROR INDICATES A POSSIBLE COUNTER BALANCE SPRING CABLE FAILURE ON AXIS 2 OF RIGHT MTM WHICH WILL AFFECT THE GRAVITY BALANCE OF MTM ARM, BUT ISI ENGINEERS DO NOT BELIEVE THAT IT WOULD CAUSE THE ALLEGED ISSUE. ON (B)(6) 2013, FSE REPLACED RIGHT MTM AND SYSTEM PASSED ALL RELATED TESTS AFTER MTM REPLACEMENT. NO OTHER SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED SINCE THE SURGEON DECIDED TO CONVERT THE DA VINCI PROCEDURE DUE TO AN OPEN PROCEDURE DUE TO THE ALLEGED ISSUE OF STUTTER MOTION ABOUT EVERY FIVE SECONDS WITH ARM 1 AND ARM 2 ON THE DA VINCI SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CARDIAC PROCEDURE, PATIENT SIDE MANIPULATOR (PSM) ARMS 1 AND 2 WERE HAVING INTERMITTENT ISSUES. THE SITE RESEATED THE STERILE ADAPTER AND TRIED NEW INSTRUMENTS, HOWEVER THE ISSUE CONTINUED TO OCCUR. THE SITE POWER CYCLED THE SYSTEM AND CONTACTED INTUITIVE SURGICAL INC.(ISI) TECHNICAL SUPPORT FOR ASSISTANCE. ISI TECHNICAL SUPPORT CONFIRMED THAT THE MASTER TOOL MANIPULATOR (MTM) FINGER CLUTCH WAS OFF. THE SITE STATED THAT THE PSM ARMS WOULD DO A STUTTER LIKE MOTION ABOUT EVERY FIVE SECONDS. DURING TROUBLESHOOTING WITH ISI TECHNICAL SUPPORT, THE SURGEON DECIDED TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO AN OPEN PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE ISI FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON SITE EVALUATION, TEST DROVE THE SYSTEM AND FOUND THAT AND THE SYSTEM PASSED ALL TESTING AND FUNCTIONED AS NORMAL. THE SURGICAL STAFF INFORMED THE FSE THAT WHEN MOVING THE CAMERA ARM, THE INSTRUMENTS INSTALLED ON PSM ARMS 1 AND 2 SEEMED TO MOVE. THE FSE WAS UNABLE TO REPLICATE THE CUSTOMER ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668760 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS 3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other