BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3568840 · Received January 10, 2014

    Report

    Report Number
    2955842-2014-00205
    Event Type
    Other
    Date Received
    January 10, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FSE'S PERFORMED FIELD EVALUATIONS AT THE SITE ON (B)(4) 2013. THE FSE'S WERE UNABLE TO REPLICATE THE REPORTED ISSUE RELATED TO INTERMITTENT ENERGY ACTIVATION ON THE SYSTEM IN ADDITION TO ISSUES WITH THE CANNULA MOUNT. THE POWER TRAY ASSEMBLY HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE RELATED TO ERROR CODE 86 CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE POWER TRAY ASSEMBLY IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI HYSTERECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING INTERMITTENT CAUTERY ISSUES. IN ADDITION, THE SURGEON CLAIMED THAT THE PATIENT WAS FOUND TO HAVE BURN MARKS AROUND THE CANNULA PORT(S) POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    THE POWER TRAY ASSEMBLY WAS RETURNED AND EVALUATED. THE PRINTED CIRCUIT ASSEMBLY (PCA) WAS INSTALLED ON AN IN-HOUSE SYSTEM. THE SYSTEM FAILED TO POWER UP AND SHOWED AN ERROR CODE. THE POWER SUPPLY WAS FOUND TO BE DEAD AND DID NOT HAVE A +12V OUTPUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE SURGEON ENCOUNTERED INTERMITTENT MONOPOLAR ENERGY ACTIVATION ISSUES. THE SURGICAL STAFF CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT FOR ASSISTANCE DURING THE EVENT. THE SURGEON INDICATED THAT NO ENERGY WAS OBSERVED FROM THE TIP OF THE MONOPOLAR INSTRUMENT ALTHOUGH HE WAS RECEIVING VISUAL INDICATORS IN THE SURGEON SIDE CONSOLE (SSC) AND THE ELECTRO SURGICAL UNIT (ESU) WAS EMITTING AN ACTIVATION TONE. THE SURGICAL STAFF REPORTEDLY REPLACED THE INSTRUMENT AND THE CAUTERY CABLE BUT THE ISSUE PERSISTED. THE SURGICAL STAFF ALSO CONNECTED THE INSTRUMENT CORD TO ANOTHER PORT ON THE PERSONALITY MODULE ENERGY DEVICE (PMED) BUT THE ISSUE WAS NOT RESOLVED. DUE TO THE INTERMITTENT MONOPOLAR ENERGY ACTIVATION ISSUES, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI HYSTERECTOMY TO OPEN SURGICAL TECHNIQUES. THE FOLLOWING DAY ON (B)(6) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPLICATE THE REPORTED INTERMITTENT MONOPOLAR ENERGY ACTIVATION ISSUE. THE FSE INSTALLED AN INSTRUMENT ON THE SYSTEM, TEST DROVE THE INSTRUMENT, AND WAS ABLE TO ACTIVATE ENERGY WITH NO ISSUES. THE FSE ALSO SWAPPED PATIENT SIDE MANIPULATORS (PSM) 1 AND 3. THE FSE WAS ABLE TO TEST DRIVE THE SYSTEM AND ACTIVATE ENERGY USING ALL THREE PSM'S. THE FSE NOTED THAT SEVERAL 282 ERROR CODES WERE FOUND IN THE SITE'S SYSTEM LOGS POINTING TO PSM 1. AN ERROR CODE 282 SIGNIFIES THAT A TOOL WAS DETERMINED TO BE INVALID BY THE SYSTEM. IN RELATION TO THE ERROR CODE 282, THE FSE INDICATED THAT POSSIBLY AN INSTRUMENT ENGAGEMENT ISSUE MIGHT HAVE CAUSED THE ENERGY ACTIVATION ISSUE. THE FSE TESTED THE SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. ON (B)(6) 2013 AND (B)(6) 2014, ISI CONTACTED THE ROBOTICS COORDINATOR FROM THE SITE, THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT THE SURGEON INFORMED HER THAT THE PATIENT CAME BACK TO THE HOSPITAL A WEEK LATER FOR A FOLLOW VISIT AND WAS FOUND TO HAVE BURN MARKS AROUND THE CANNULA PORTS. THE INITIAL REPORTER WAS UNABLE TO PROVIDE ANY DETAILS REGARDING THE BURN MARKS. ISI HAS ATTEMPTED TO CONTACT THE SURGEON 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. ON (B)(6) 2013, ANOTHER FSE VISITED THE SITE AND PERFORMED A FIELD EVALUATION. AT THE START OF THE FIELD EVALUATION, THE FSE ENCOUNTERED AN ERROR CODE 86 ON THE SYSTEM WHICH IS UNRELATED TO THE REPORTED CAUTERY ISSUES. AN ERROR CODE 86 SIGNIFIES AN OUT-OF-RANGE VOLTAGE VALUE WAS READ FROM A POWER DISTRIBUTION BOARD (IPD/GPD) ADC REGISTER. THE FSE RESOLVED THE ERROR CODE 86 ISSUE BY REPLACING THE POWER TRAY ASSEMBLY. THE FSE PERFORMED AN ELECTRICAL SAFETY TEST ON THE SYSTEM AS WELL AS A COMPLETE TEST TO VERIFY ELECTRICAL ISOLATION OF THE CANNULA MOUNT ASSOCIATED WITH THE BURN SITE. THE FSE CONFIRMED THAT THE CANNULA MOUNT HAD A RESISTANCE OF 0 OHMS AGAINST THE GROUND SCREW. THE FSE TESTED THE SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19276 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other