BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3120747 · Received May 20, 2013

    Report

    Report Number
    2955842-2013-01759
    Event Type
    Other
    Date Received
    May 20, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE GUSP (GEMINI USER SWITCH PANEL)WAS RETURNED TO ISI FOR INVESTIGATION AND WAS EVALUATED BY ENGINEERING WITH THE FOLLOWING FINDINGS: ENGINEERING WAS UNABLE TO REPRODUCE THE ALLEGED FAILURE REPORT BY INSTALLING THIS BOARD INTO PCA SYSTEM AND RUN X50 POWER CYCLES. THE UNIT WAS WORKING FINE WITHOUT ANY ISSUES. ENGINEERING OBSERVED THE POWER BUTTON WAS STICKY AND THE POWER COVER WAS BROKEN.

    Additional Manufacturer Narrative · 1

    ISI REGULATORY COMPLAINT ANALYST ATTEMPTED TO GET IN CONTACT WITH THE SITE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, HAS BEEN UNSUCCESSFUL TO GET IN CONTACT WITH THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON CONTACTED THE FIELD SERVICE ENGINEER (FSE), WHO THEN CONTACTED ISI TECHNICAL SUPPORT FOR A NON-RECOVERABLE ERROR MESSAGE 30253 ON THEIR DA VINCI S (IS2000) SYSTEM DURING A SURGICAL PROCEDURE. AN ERROR 30253 MEANS THAT THE AMPS DIDN'T TURN ON DUE TO THE FAILURE REACTION LOGIC (FRL) BEING TRIGGERED. THE LOGS ON THE SYSTEM WERE REVIEWED ONSITE AND THE FIELD SERVICE ENGINEER (FSE) NOTICED A LONG LIST OF ERROR 256 (WHICH MEANS THE EMERGENCY STOP SWITCH WAS PRESSED, THIS IS WHERE THE SUPERVISOR RECOVERED THE SYSTEM FROM A RECOVERABLE FAULT), ERROR 10025 (MEANS THAT AMPS DON'T ENABLE DUE TO ESTOP)AND ERROR 283 (MEANS ESTOP IS PRESSED). THE SURGEON CONFIRMED THAT HE ONLY PRESSED THE E-STOP ONCE BY MISTAKE AT THE BEGINNING. THE SITE REBOOTED THE SYSTEM; HOWEVER, REBOOTING LED TO THE FOLLOWING ERRORS ON THE MANUFACTURER SAFETY DATA SHEET (MSDS), 30253 AND 213 (MEANS THE MOTORIZED ARM DID NOT COMPLETE ITS STARTUP SEQUENCE , THE SYSTEM FAULTS AND TRANSITIONS TO A SAFE STATE). ISI TECHNICAL SUPPORT RECOMMENDED THE FIELD SERVICE ENGINEER (FSE) TO HAVE THE SITE EMERGENCY POWER OFF (EPO) THE SURGEON SIDE CART (SSC). FIELD SERVICE ENGINEER (FSE) DID THAT A FEW TIMES AND THE ISSUE WAS NOT RESOLVED. IT WAS RECOMMENDED THAT THE SITE MOVE THE MASTER TOOL MANIPULATOR (MTMS) AND RESTART THE SYSTEM. THIS WAS DONE AND THE SYSTEM CAME UP OK. THE SURGEON CALLED BACK LATER THE SAME DAY WITH THE SAME ISSUE AND HAD A FEW 10025 ERRORS ON THE SCREEN THAT HE WAS ABLE TO RECOVER; HOWEVER, THEN IT BECAME HARD TO RECOVER FROM THE ERROR MESSAGE. ISI TECHNICAL SUPPORT ADVISED THE SURGEON TO RESTART THE SYSTEM AND DOING THAT TRIGGERED ERROR 30253 AGAIN. SURGEON WAS ADVISED TO EMERGENCY POWER OFF (EPO) THE CONSOLE TWICE AND RESTART NORMALLY A THIRD TIME, BUT THAT WAS IMPOSSIBLE DUE TO THE ERROR MESSAGE. ISI TECHNICAL SUPPORT THEN ADVISED THE SITE TO CYCLE THE E-STOP BUTTON SEVERAL TIMES AND MOVED THE MASTER TOOL MANIPULATOR (MTMS) AROUND. THEY TRIED ONE LAST TIME TO EMERGENCY POWER OFF (EPO) BUT THE SYSTEM CAME BACK WITH THE ERROR 30253. DUE TO THE ALLEGED ERROR MESSAGES, THE SURGEON DECIDED TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN PROCEDURE AND WOULD POSTPONE HIS DA VINCI PROCEDURE HE HAD LATER THAT AFTERNOON. INTUITIVE SURGICAL INC. (ISI) IS ORDERING A GUSP (GEMINI USER SWITCH PANEL), IOP (I/O PROCESSOR) AND SYSTEM CONTROL PROCESSOR BOARD (SCPZ) FOR THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222604 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

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