BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 4027561 · Received August 21, 2014

    Report

    Report Number
    2955842-2014-05103
    Event Type
    Other
    Date Received
    August 21, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 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

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE REPORTED ISSUE BY INSTALLING THE CFG BOARD INTO A PCA SYSTEM AND IT FAILED TO POWER ON THE PSC. FAILURE ANALYSIS WAS UNABLE TO POWER ON THE PSC. FA WAS UNABLE TO REPLICATE THE REPORTED ERROR CODE 25310 SINCE THE PSC DID NOT POWER ON. ONLY THE D10 LED FROM THE PPD BOARD WAS ON. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE REPORTED ERROR MESSAGE AND THE SURGEON MADE THE DECISION TO WAKE THE PATIENT UP FROM ANESTHESIA AND PROCEEDED TO HAVE THE PATIENT UNDERGO THE PROCEDURE USING ANOTHER DA VINCI SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PARTIAL GASTRECTOMY PROCEDURE A REPORTED ERROR CODE 25310 APPEARED ON THE SYSTEM AFTER DRAPING THE SYSTEM. AN ERROR CODE 25310 IS A CONTROL & TRANSFORM PROCESSOR (CTP) INTERRUPT SERVICE REQUEST (IRQ) ERROR. IT INDICATES EITHER THAT SERVO INTERRUPT FROM HARDWARE DID NOT OCCUR, OR THERE WAS AN IRQ EXECUTION TIMEOUT ERROR. IT WAS NOTED THAT THE SURGICAL STAFF DID NOT TOUCH THE SYSTEM WHEN THE ERROR CODE APPEARED. THE SURGICAL STAFF TRIED TO REBOOT THE SYSTEM; HOWEVER, THE MESSAGE, PATIENT CART NOT CONNECTED APPEARED ON THE MONITOR. THE SURGICAL STAFF TRIED TO EMERGENCY POWER OFF (EPO) AND REBOOT THE SYSTEM SEVERAL TIMES; HOWEVER, THE ISSUE PERSISTED. THE BATTERY CHARGING STATUS LED WAS NOT INDICATING WITH BOTH NORMAL MODE AND STAND-ALONE MODE AT THE TIME. WHEN THE ERROR CODE APPEARED, THE PATIENT WAS ALREADY UNDER ANESTHESIA. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO WAKE THE PATIENT UP, PUT THE PATIENT IN ANOTHER ROOM, AND COMPLETE THE SURGERY USING ANOTHER DA VINCI SURGICAL SYSTEM. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE AND PERFORMED A FIELD EVALUATION. THE FSE CHECKED THE BATTERY INDICATOR LED ON THE TILLER WHILE THE AC CORD FOR THE PATIENT SIDE CART (PSC) WAS CONNECTED, BUT THE LEDS WERE NOT ILLUMINATED. THE FSE PRESSED THE CART POWER ON THE TILLER; HOWEVER, THE PSC DID NOT POWER ON AND THE CART POWER BUTTON DID NOT ILLUMINATE. THE FSE CONFIRMED THAT THE FAN ON THE MEDICAL GRADE POWER SUPPLY (MGPS) WAS SPINNING. THE FSE CONFIRMED THAT THE D10 LED ON THE PATIENT-SIDE POWER DISTRIBUTION BOARD (PPD) AND THE D5 LED ON THE AUXILIARY POWER BOARD (APB) WERE ILLUMINATED IN GREEN. THE MGPS WAS WORKING GOOD AND A BAD PPD WAS CAUSING THE ISSUE. THE FSE REPLACED PPD AND THE PRINTED CIRCUIT ASSEMBLY (PCA) AND THE SYSTEM FUNCTIONED PROPERLY. THE SYSTEM TESTED TO ORIGINAL EQUIPMENT MANUFACTURER SPECIFICATIONS. ON (B)(4) 2014, ISI OBTAINED ADDITIONAL INFORMATION FROM THE SITE: PRIOR TO WAKING THE PATIENT UP, PORTS WERE ALREADY PLACED IN THE PATIENT; HOWEVER, THE SYSTEM WAS NOT DOCKED TO THE PATIENT. THE PATIENT WAS TAKEN TO THE OTHER ROOM TO COMPLETE THE SURGERY. THE PATIENT TOLERATED THE DA VINCI PROCEDURE WELL AND WAS DISCHARGED ON (B)(4) 2014. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507202 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other