BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 8384629 · Received March 2, 2019

    Report

    Report Number
    2955842-2019-10153
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 6, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER DID NOT REPLACE ANY PARTS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE SYSTEM HAD A NON-RECOVERABLE FAULT WHEN DEPLOYING FOR DOCKING. ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT WHEN HITTING THE ¿DEPLOY FOR DOCKING¿ BUTTON THEY OBSERVED A NON-RECOVERABLE ERROR. THE TECHNICAL SERVICE ENGINEER HAD THE CUSTOMER DO A HARD RESET ON THE PATIENT SIDE CART (PSC) AND RESEAT THE FIBER CABLES WHILE THE SYSTEM WAS OFF. WHEN THE CUSTOMER REBOOTED THE SYSTEM AND PRESSED THE DEPLOY FOR DOCKING BUTTON THE ERROR RETURNED. THE POP UP LOGS NOTED ERROR 23138. THE CUSTOMER CALLED BACK INTO TECHNICAL SUPPORT AND THE CUSTOMER STATED THE DOCTOR DECIDED TO CONVERT THE SURGERY TO OPEN SURGERY. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE INFORMED THAT TROUBLESHOOTING WAS DONE WITH TECHNICAL SUPPORT WITH NO RESOLVE. THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY BECAUSE THE ROBOT WOULD NOT DEPLOY. THE NURSE CONFIRMED THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO PATIENT INJURY OR HARM. THE TECHNICAL SERVICE MANAGER (TSM) THEN INFORMED THAT REBOOTING THE SYSTEM WAS ALL THE TECHNICAL SERVICE ENGINEER WAS ABLE TO DO, WHICH WAS PERFORMED BY THE CUSTOMER. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FIELD SERVICE ENGINEER CONFIRMED THE SYSTEM WOULD NOT START UP WITHOUT ERROR 23128. THE FIELD SERVICE ENGINEER ROTATED THE ORIENTING PLATFORM (OP) SEVERAL TIMES AND ON ATTEMPT NUMBER FIVE, THE SYSTEM STARTED WITHOUT ERRORS. THE FIELD SERVICE ENGINEER SWAPPED THE UNIVERSAL MOTION CONTROLLERS (UMC) AND PROGRAMMED TURNED ON THE SYSTEM WITHOUT ERRORS SEVERAL TIMES IN A ROW. THEN THE FIELD SERVICE ENGINEER CHECKED THE AXES CONTROLLER PLATFORM (ACP) FIVE CONNECTIONS TO ENSURE EVERYTHING WAS IN PLACE, AND NOTICED THE ACP 5 BOARD HAD NO SCREWS HOLDING THE BOARD IN PLACE. THE FIELD SERVICE ENGINEER NOTED THE BOARD WAS LIKELY TO BE THE CAUSE FOR THE ERROR. THE FIELD SERVICE ENGINEER SECURED THE ACP 5 IN PLACE. THE SYSTEM WAS TURNED ON/OFF FOR AN HOUR AND THE FIELD SERVICE ENGINEER OPERATED THE BOOM, ROTATED, EXTENDED, DEPLOYED FOR DOCKING, AND STOWED SEVERAL TIMES WITHOUT ERRORS. NO PART REPLACEMENT WAS REQUIRED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177997 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-42

    Patients

    Seq Age Sex Outcome Treatment
    1