BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3215235 · Received July 10, 2013

    Report

    Report Number
    2955842-2013-02484
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 9, 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

    ENGINEERING EVALUATION OF THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 ON A SERVICE TEST SYSTEM FOUND THAT NO INTERMITTENT BINDING (RESISTANCE) WAS EXPERIENCED AT THE MASTER TOOL MANIPULATORS (MTMS). AXIS ONE OF THE PSM ARM FAILED A TORQUE RIPPLE TEST FOR HIGH FRICTION VALUE ON ONE OF THE GEARS; HOWEVER THIS AXIS HAD LOW OVERALL FRICTION. ENGINEERING EVALUATION OF PSM 1 ALSO FOUND THAT AXIS TWO ON THE PSM ARM FAILED A BRAKE WEIGHT TEST. THE CABLE ON AXIS 4 SHOWED EVIDENCE OF SLIGHT TWISTING AND WAS ALSO REPLACED. ENGINEERING EVALUATION OF PSM 2 ARM ON A SERVICE TEST SYSTEM FOUND THAT NO INTERMITTENT BINDING (RESISTANCE) WAS EXPERIENCED AT THE MASTER TOOL MANIPULATORS (MTMS). AXIS ONE OF THE PSM ARM FAILED A TORQUE RIPPLE TEST FOR HIGH FRICTION VALUE ON ONE OF THE GEARS; HOWEVER THIS AXIS HAD LOW OVERALL FRICTION. AXIS ONE OF THE PSM ALSO EXHIBITED A PROTRUSION (HARD BURR) WITHIN THE SQUARE HOLE OF THE ALUMINUM-BRONZE FRICTION DISK OF THE BRAKE. THE SHAFT FREELY SLIDES IN AND OUT OF THE FRICTION DISK, HOWEVER IT IS BELIEVED THAT THIS PROTRUSION, UNDER CERTAIN PSM ARM ORIENTATIONS AND SPEED-CONDITIONS, MAY INTERMITTENTLY CAUSE THE FRICTION DISK TO LOCK WITH THE SHAFT AND NOT ALLOW THE BRAKE TO PROPERLY RELEASE. AXIS TWO ON THE PSM ARM EXHIBITED A CONTAMINANT ON THE DRIVE SHAFT AND ON SEVERAL LOCATIONS OF THE BRAKE FRICTION DISK. THE CONTAMINATE WAS ANALYZED AND FOUND TO BE OIL FROM THE BEARING, HOWEVER, NO SUCH OIL WAS FOUND ON THE FRICTION SURFACE OF THE BRONZE FRICTION DISK. THE CONCLUSION OF THE FAILURE EVALUATION INVESTIGATION FOUND THAT WHEN TOTAL FRICTION WITHIN THE DRIVE TRAIN OF THE PSM INCREASES IN CERTAIN ORIENTATIONS, THE PSM CAN INTERMITTENTLY STALL. THE INTERMITTENT STALLING MAY BE FELT AS CORRESPONDING RESISTANCE AT THE MTMS. THIS FRICTION CAN BE CAUSED BY CONTAMINANTS OR BURRS, AS NOTED ON PSM 2. A VIDEO RECORDING OF THE SURGICAL PROCEDURE WAS ALSO PROVIDED BY THE SITE. THE VIDEO WAS REVIEWED BY CLINICAL AND ENGINEERING TEAMS AT ISI. REVIEW OF THE VIDEO FOUND THAT PSM ARM 2, WHICH HAD THE MONOPOLAR CURVED SCISSORS INSTRUMENT INSTALLED, WAS NOT MOVING WITH SMOOTH, FLUID MOTION. THIS IRREGULAR MOTION WAS LIKELY FELT AS RESISTANCE BY THE SURGEON WHEN USING THE MTMS.

    Additional Manufacturer Narrative · 1

    THE FIELD INVESTIGATION CONDUCTED BY THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE DURING FUNCTIONAL TESTING OF THE SITE'S SYSTEM USING TEST INSTRUMENTS, A TEST DRAPE AND CANNULA. HOWEVER, AFTER POWERING OFF THE SYSTEM, AND MOVING AXIS 1 OF PATIENT SIDE MANIPULATOR (PSM) ARM 1 THE FSE NOTED THAT AXIS 1 BRAKE WOULD NOT MOVE, EVEN AFTER PRESSING THE CLUTCH BUTTON ON THE PSM. THE FSE BURNISHED THE AXIS, HOWEVER, THE ISSUE PERSISTED. AXIS 1 ON PSM 2 AND PSM 3 WERE ALSO BURNISHED; HOWEVER, THE FSE WAS ABLE TO MOVE THE PSMS. REVIEW OF THE SITE'S SYSTEM LOGS BY THE FSE FOUND NO SYSTEM ERROR CODES WERE GENERATED THAT CAUSED OR CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE SITE. PSM 1 WAS REPLACED TO REPAIR THE SYSTEM. AS A PRECAUTION, PSM 2 WAS ALSO REPLACED. PSM 1 AND PSM 2 HAVE BEEN RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION. AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED, AS EVALUATION OF THE AFFECTED PARTS IS CURRENTLY UNDERWAY. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA AFTER THE EVALUATIONS HAVE BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INSTALLED ON PSM 1 DURING THE SURGICAL PROCEDURE WAS RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION. ENGINEERING EVALUATION WAS UNABLE TO REPLICATE THE SUDDEN MOVEMENT EXPERIENCED BY THE SITE. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTING WHILE INSTALLED ON AN IS3000 IN-HOUSE SYSTEM. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS OPENED AND CLOSED PROPERLY. ON (B)(4) 2013 ISI CONTACTED THE INITIAL REPORTER OF THIS EVENT. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS IN STABLE CONDITION AND HAD NOT YET BEEN RELEASED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION CONCERNING THE PATIENT'S STATUS HAS BEEN PROVIDED. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, WITH THE USE OF DUAL SURGEON SIDE CONSOLES (SSCS), DURING DISSECTION THE PATIENT'S URETHRA, THE SURGEON EXPERIENCED RESISTANCE ON PATIENT SIDE MANIPULATOR (PSM) ARMS 1 AND 2 WHILE MANIPULATING THE MASTER TOOL MANIPULATORS (MTMS) ON THE SURGEON SIDE CARTS (SSC). THE SURGEON CONTINUED TO MANIPULATE THE MTMS WHEN PSM 1 SUDDENLY MOVED, CAUSING THE INSTALLED MONOPOLAR CURVED SCISSORS INSTRUMENT TO CUT THE PATIENT'S URETHRA. THE SURGEON RECONSTRUCTED THE AFFECTED AREA TO REPAIR THE DAMAGE TO THE PATIENT'S URETHRA AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE DA VINCI SURGICAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319408 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DAV SURG. SYSTEM, INSTRUMENT, ACCESSORIES & ESU