BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3800937 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02874
    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
    MA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD INVESTIGATION WAS CONDUCTED BY AN ISI FIELD SERVICE ENGINEER (FSE). THE FSE WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE OF PSM 2 JUMPING INWARD. DURING THE FSE'S SITE VISIT, THE FSE DISCUSSED THE REPORTED EVENT WITH THE SITE'S ROBOTICS COORDINATOR AND A NURSE THAT WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED BY THE NURSES, THE RESIDENT DOCTOR EXPERIENCED SOME RESISTANCE WHILE ATTEMPTING TO ADVANCE THE INSTRUMENT INTO THE PATIENT AND AS THE RESIDENT DOCTOR CONTINUED TO PUSH DOWN ON AXIS 3 ON PSM 2, THE RESISTANCE CEASED AND AXIS 3 MOVED IN RAPIDLY. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, WHICH PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE FSE USED TEST INSTRUMENTS TO TEST THE PERFORMANCE OF THE SITE'S SYSTEM. UPON INSERTION OF THE TEST INSTRUMENTS, THE INSTRUMENTS WERE RECOGNIZED WITH NO ISSUES NOTED. ALL OF THE CLUTCH BUTTONS ON PSM 2 WERE FOUND TO FUNCTION PROPERLY. THERE WAS NO PHYSICAL DAMAGE TO THE PSM OBSERVED. FRICTION TESTING OF THE PSM'S AXIS FOUND THAT THEY FUNCTIONED WITHIN SPECIFICATION AND THE PSM'S CABLE TENSIONS WERE WITHIN SPECIFICATIONS. THE FSE ALSO TEST DROVE THE SYSTEM WITH A TEST ENDOSCOPE INSTALLED AND THERE WERE NO ISSUES OR FAULTS OBSERVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI SURGICAL PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO THE VENA CAVA REQUIRING THE SURGEON TO CONVERT THE SURGICAL PROCEDURE TO AN OPEN SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, DURING INSERTION OF AN ENDOWRIST INSTRUMENT INTO THE PATIENT, WHILE INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 2, THE SURGICAL STAFF OBSERVED THAT THE LIGHT EMITTING DIODE (LED) ON PSM 2 STARTING FLASHING AND THE PSM RAPIDLY JUMPED INWARD, CAUSING THE INSTALLED INSTRUMENT TO PUNCTURE THE PATIENT'S VESSEL. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ASSISTANCE. REVIEW OF THE SITE'S SYSTEM LOGS BY A TECHNICAL SUPPORT ENGINEER (TSE) FOUND THAT THE SITE EXPERIENCED MULTIPLE INSTANCES OF SYSTEM ERROR CODE 31009 AND SYSTEM ERROR CODE 282 ON PSM 2 INDICATING THAT THE INSTALLED INSTRUMENT WAS NOT RECOGNIZED BY THE DA VINCI SURGICAL SYSTEM. BASED ON THE DESCRIPTION OF THE EVENT PROVIDED BY THE CUSTOMER, THE TSE DETERMINED THAT THE ISSUE EXPERIENCED BY THE SITE WAS DUE TO THE CUSTOMER'S EXPECTATION OF A GUIDED TOOL CHANGE (GTC). THE TSE PROVIDED THE CUSTOMER WITH AN EXPLANATION CONCERNING THE DA VINCI SURGICAL SYSTEM'S GTC FUNCTIONALITY. THE GTC PROVIDES AN EFFICIENT AND SAFE METHOD FOR INSTRUMENT INSERTION, THE SYSTEM CAN ASSIST THE PATIENT SIDE CART OPERATOR BY GUIDING AN INSTRUMENT INTO THE PATIENT. GTC ONLY WORKS WHEN AN INSTRUMENT HAS BEEN REPLACED. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO ALLOW FOR REPAIR OF THE PATIENT'S VESSEL AND COMPLETION OF THE SURGICAL PROCEDURE. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE ROBOTICS COORDINATOR, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. SHE INDICATED THAT DURING THE FIRST INSTALL OF A MARYLAND BIPOLAR FORCEPS INSTRUMENT ONTO PSM 2, THE RESIDENT DOCTOR EXPERIENCED ISSUES. THE RESIDENT DOCTOR UNINSTALLED AND RE-INSTALLED THE INSTRUMENT ONTO PSM 2 AND WHILE THE INSTRUMENT WAS ADVANCING INTO THE PATIENT, THE RESIDENT OBSERVED THAT THE INSTRUMENT JUMPED CAUSING AN INJURY TO THE PATIENT'S VENA CAVA. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AND A VASCULAR SURGEON WAS CONSULTED. EXAMINATION OF THE PATIENT'S VESSEL BY THE VASCULAR SURGEON FOUND THAT THE PATIENT HAD SUSTAINED AN INJURY OVER THE INFERIOR VENA CAVA. NO SURGICAL REPAIR OF THE AFFECTED AREA WAS REQUIRED. A HEMOSTATIC AGENT WAS APPLIED TO THE AFFECTED AREA TO ALLOW FOR THE DEFECT TO HEAL ON ITS OWN. THE PATIENT LOST 500 CC OF BLOOD; HOWEVER, IT IS UNKNOWN IF THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE ROBOTICS COORDINATOR INDICATED THAT THE PATIENT IS RECOVERING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277503 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other