BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3821116 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03093
    Event Type
    Other
    Date Received
    May 20, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    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

    THE POWER SUPPLY HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE POWER SUPPLY IS RETURNED (POST FAILURE ANALYSIS) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO AN ERROR CODE 25326, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE POWER SUPPLY INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. FAILURE ANALYSIS WAS ABLE TO REPLICATE THE FAILURE REPORTED ISSUE BY INSTALLING UNIT INTO PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND IT FAILED TO POWER ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ERROR CODE 25326. THE ERROR MESSAGE WAS POINTING TO REMOTE COMPUTE ENGINE (RCE) 1. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION: THE INITIAL REPORTER CONFIRMED THAT THEY ENCOUNTERED AN ERROR CODE 25326 AFTER THE STARTUP OF THE DA VINCI SYSTEM. AN ERROR CODE 25326 MEANS, THAT THE COMMUNICATION TIMED OUT. THE SYSTEM WAS TESTED AND IT WAS NOTED THAT THE PATIENT SIDE CART (PSC) DID NOT START UP ALL TOGETHER WITH THE SURGEON SIDE CONSOLE (SSC) AND THE MONITORING CART. THE SURGICAL STAFF DECIDED TO START UP THE PSC SEPARATELY AND ENCOUNTERED 3 YELLOW LED'S ON THE BATTERY DISPLAY OF THE PSC. THE POWER DISPLAY WAS DECREASING. IT WAS NOTED THAT THE PSC WAS RUNNING ON BATTERY POWER AND DID NOT SWITCH TO THE AC POWER. THE INITIAL REPORTER REPLACED THE POWER CABLE AND CHECKED THAT THE WALL SOCKET HAD GOOD POWER FUNCTION; HOWEVER, THE ISSUE PERSISTED. THE PATIENT WAS UNDER ANESTHESIA FOR ABOUT 1.5 HOURS AND SURGICAL PORTS WERE NOT PLACED ON THE PATIENT AT THE TIME OF THE EVENT. THE DA VINCI SURGICAL PROCEDURE WAS NOT STARTED AT THE TIME OF THE EVENT. DUE TO THE ALLEGED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS TO BE RESCHEDULED TO A FUTURE DATE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE EVENT. THE POWER SUPPLY WAS REPLACED AND NO PROBLEMS HAVE BEEN REPORTED AFTER THE REPLACEMENT OF THE POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298742 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R