BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3987959 · Received August 7, 2014

    Report

    Report Number
    2955842-2014-04791
    Event Type
    Other
    Date Received
    August 7, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY WAS RETURNED WITH THE FOLLOWING INFORMATION: FAILURE ANALYSIS WAS ABLE TO REPLICATE THE REPORTED FAILURE BY INSTALLING THE UNIT INTO A PCA SYSTEM AND THE POWER SUPPLY FAILED TO POWER ON. ISI ENGINEERING REVIEWED THE ERROR LOG AND BELIEVED THAT ERROR CODE 25310 WAS TRIGGERED DUE TO POWER INTERRUPTION WITHIN SUBSYSTEMS ON THE PSC. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE REPORTED ISSUE WITH THE SYSTEM, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) WOULD NOT POWER UP. THE SURGICAL STAFF WAS ABLE TO POWER THE SYSTEM UP LATER; HOWEVER, THE SYSTEM WENT INTO BATTERY MODE. IT WAS REPORTED THAT A CHECK FIBER MESSAGE SHOWED UP ON THE SCREEN. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE POST-ANESTHESIA. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) REVIEWED THE SITE'S SYSTEM LOGS WHICH SHOWED THAT THE PSC WAS NOT CHARGING WHEN PLUGGED IN AND ALL THE LEDS WERE OFF. THE MEDICAL GRADE POWER SUPPLY (MGPS) FAN WAS NOT RUNNING. THE SITE VERIFIED INCOMING POWER ON THE POWER ENTRY MODULE. THE MGPS WAS REPLACED AND THE SYSTEM VERIFICATION WAS COMPLETED. ON (B)(4) 2014, ISI FOLLOWED UP WITH THE INITIAL REPORTER REGARDING THIS COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION: DURING THE SETUP OF THE SYSTEM, THE MONITOR OF THE VISION CART SHOWED AN ERROR CODE 25310. AN ERROR CODE 25310 IS A CONTROL & TRANSFORM PROCESSOR (CTP) INTERRUPT SERVICE REQUEST (IRQ) ERROR. THIS ERROR INDICATES EITHER THAT SERVO INTERRUPT FROM HARDWARE DID NOT OCCUR, OR THERE WAS AN IRQ EXECUTION TIMEOUT ERROR. THE POWER SUPPLY FAILED JUST AFTER THE SURGEON HAD DOCKED THE PATIENT CART. PORTS WERE PLACED IN THE PATIENT; HOWEVER, THE PROCEDURE WAS NEVER STARTED. THE INSTRUMENTS HAD NOT YET BEEN INSERTED INTO THE DA VINCI SYSTEM WHEN THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA FOR ABOUT 2 HOURS PRIOR TO ABORTING THE CASE. THE SURGERY WAS RESCHEDULED ON (B)(6) 2014 AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466135 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other