BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3238476 · Received July 19, 2013

    Report

    Report Number
    2955842-2013-02662
    Event Type
    Other
    Date Received
    July 19, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) CONCLUDED THAT THE SURGEON WAS UNABLE TO TAKE CONTROL OF THE MASTER TOOL MANIPULATORS (MTMS) DURING THE SURGICAL PROCEDURE DUE TO THE TORQUE PLACED ON THE PATIENT SIDE MANIPULATOR (PSM) ARM WHEN THE PATIENT MOVED. THE FSE RE-TRAINED THE SITE ON HOW PRESS THE CLUTCH BUTTONS ON THE PSM AND MOVE THE PSM TO RELIEVE THE PRESSURE ON THE PSMS SHOULD THE ISSUE RECUR DURING FUTURE DA VINCI SURGICAL PROCEDURES. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT THE SURGICAL PROCEDURE WAS IN PROGRESS APPROXIMATELY 20 MINUTES WHEN THE REPORTED ISSUE OCCURRED. PER THE INITIAL REPORTER ONLY THE PATIENT'S ABDOMEN MOVED. THE PATIENT HAD A HEAVY ABDOMINAL PANNUS. THE PATIENT WAS AT A LEVEL POSITION WHEN THE PORT SITE INCISIONS WERE CREATED. AFTER CREATION OF THE PORT INCISIONS, THE PATIENT WAS PLACED IN THE TRENDELENBURG POSITION, THUS CAUSING THE PATIENT'S ABDOMEN TO SHIFT. PER THE INITIAL REPORTER, THERE HAVE BEEN NO OTHER OCCURRENCES OF THE ISSUE AT HOSPITAL SINCE THE SURGICAL STAFF WAS RE-TRAINED ON HOW TO RELIEVE PRESSURE ON THE PSM. THE DA VINCI SI USER MANUAL SPECIFICALLY STATES: WARNING: ONCE THE DA VINCI SI SYSTEM IS POSITIONED, CANNULAE ARE PLACED IN THE PATIENT AND PATIENT CART ARMS ARE ATTACHED TO THE CANNULAE, THE SURGICAL TABLE MUST NOT BE MOVED IN ANY WAY. SERIOUS INJURY COULD RESULT. IF INTRAOPERATIVE OR TABLE MOVEMENT IS NECESSARY, UNDOCK THE DA VINCI SI SYSTEM, MOVE THE OR TABLE AND RE-DOCK THE SYSTEM. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES AFTER OBSERVING MOVEMENT OF THE PSM DUE TO ADJUSTMENT OF THE PATIENT POSITION DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, WHEN THE SURGEON TOOK CONTROL OF THE MASTER TOOL MANIPULATORS (MTM) AT THE SURGEON SIDE CONSOLE, THE PATIENT SIDE MANIPULATOR ARM 1 MOVED TO THE SIDE. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ASSISTANCE. WHILE THE SURGICAL STAFF WAS ATTEMPTING TO TROUBLE-SHOOT THE ISSUE WITH THE TECHNICAL SUPPORT ENGINEER (TSE), THE SURGEON MADE THE DECISION TO COMPLETE THE SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. THE TSE WAS TOLD BY THE SITE THAT THE PATIENT HAD SLIPPED ON THE PATIENT TABLE APPROXIMATELY 2 INCHES. THE TSE EXPLAINED TO THE SURGICAL STAFF THAT THE PRESSURE PLACED ON THE CANNULA DUE TO MOVEMENT OF THE PATIENT CAUSED THE PSM TO MOVE WHEN THE SURGEON MANIPULATED THE MTMS. THE TSE ADVISED THE SITE THAT PRESSING THE CLUTCH BUTTONS ON THE PSM AND MOVING THE PSM WOULD HAVE RESOLVED THE ISSUE. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337051 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

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