BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3738716 · Received April 10, 2014

    Report

    Report Number
    2955842-2014-02129
    Event Type
    Other
    Date Received
    April 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PSM3 WAS RETURNED TO ISI AND EVALUATED. THE REPORTED ERROR CODES 281, 307, AND 23034 COULD NOT BE REPLICATED WITH FAILURE ANALYSIS OF PSM3. A VISUAL INSPECTION OF THE PSM3 FOUND NOTHING UNUSUAL. HOWEVER, AXIS 1 AND 2 WERE BOTH FOUND TO HAVE LOW VISCOUS FRICTION. SUJX WAS ALSO RETURNED AND EVALUATED. DURING FAILURE ANALYSIS OF SUJX, A COMMUNICATION ERROR CODE 23 WAS ENCOUNTERED. THE ERROR OCCURRED WHEN WIGGLING THE CABLE HARNESS IN AN UP AND DOWN MOTION DURING SINE CYCLE. UNRELATED TO THE REPORTED ERROR CODE 281 ISSUE, RAC3 WAS RETURNED AND EVALUATED. FAILURE ANALYSIS OF RAC3 CONFIRMED BROKEN SCREWS ON THE MOUNTING PLATE. RAC3 ALSO FAILED A SYSTEM TEST. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, BASED ON THE SYSTEM LOGS, THE ERROR CODES 281, 307, 308, AND 23034 WERE CONFIRMED TO HAVE OCCURRED THAT DAY AFTER THE SURGICAL PROCEDURE WAS COMPLETED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE POST-ANESTHESIA AFTER ENCOUNTERING AN ERROR CODE 281 ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ERROR CODE 281. AN ERROR CODE 281 SIGNIFIES A FAULT DURING SYSTEM'S START UP SEQUENCE. THE SURGICAL STAFF POWER CYCLED THE SYSTEM SEVERAL TIMES; HOWEVER, THE ISSUE PERSISTED. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE AFTER ANESTHESIA HAD ALREADY BEEN ADMINISTERED TO THE PATIENT. AT THE TIME THE EVENT OCCURRED, THE SURGICAL STAFF HAD CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND NOTED THE FOLLOWING ERROR CODES HAD OCCURRED THAT DAY: 281, 307, 308, AND 23034. ERROR CODE 307 WAS REPORTED BY THE PATIENT CART CONTROLLER (PCC) BECAUSE IT COULD NOT COMMUNICATE WITH THE EMBEDDED SERIALIZER FOR MASTER-ARM (ESMX) AND EMBEDDED SERIALIZER SETUP JOINT 4 (ESSJ4). AN ERROR CODE 307 IS A NON-RECOVERABLE ERROR INDICATING THAT A NODE CONFIGURED TO BE PRESENT DID NOT RESPOND. ERROR CODE 308 WAS REPORTED BY THE PCC BECAUSE IT WAS NOT ABLE TO COMMUNICATE WITH THE REMOTE ARM CONTROLLER BOARD 4 (RAC4). AN ERROR CODE 308 IS AN INFORMATIONAL ERROR INDICATING THAT A NODE/COMPONENT CONFIGURED TO BE PRESENT DID NOT RESPOND TO THE SUBSYSTEM CONTROLLER HEARTBEAT. ERROR CODE 23034 WAS REPORTED BY PATIENT SIDE MANIPULATOR 3 (PSM3). AN ERROR CODE 23034 IS A REMOTE COMPUTE ENGINE (RCE) STUCK SWITCH FAULT. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REPAIRED THE SYSTEM BY REPLACING PATIENT SIDE MANIPULATOR 3 (PSM3). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. AFTER REPLACING PSM3, THE FSE ENCOUNTERED WHEEL FAULTS (COMMUNICATION ERRORS) ON ARMNET 3 WHEN STOWING THE ARM. THE FSE OBSERVED ALL BUT TWO MOUNTING SCREWS ON RAC3 WERE STRIPPED. THE FSE REPLACED SET UP JOINT X (SUJX) AND RAC3. THE FSE THEN TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. ON (B)(4) 2014, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. ACCORDING TO THE INITIAL REPORTER, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE DUE TO ISSUES WITH THE PATIENT'S ANATOMY AND ALSO BECAUSE OF THE ERROR CODE 281 ISSUE. AFTER THE SURGICAL PROCEDURE WAS ABORTED, THE PATIENT WAS AWAKENED. THE SURGICAL PROCEDURE WAS RESCHEDULED FOR LATER THAT SAME DAY USING A DIFFERENT DA VINCI SURGICAL SYSTEM AT THE SITE. THE INITIAL REPORTER INDICATED THAT THE RESCHEDULED PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO OPERATIVE COMPLICATIONS WERE REPORTED. THE INITIAL REPORTER ALSO STATED THAT THE ERROR CODE 281 ISSUE WAS RESOLVED AFTER THE FSE REPLACED PSM3 AND THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216574 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other