BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 21905263 · Received April 24, 2025

    Report

    Report Number
    2955842-2025-16741
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 28-MAY-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MEDWATCH REPORT WITH USER FACILITY REPORT #(B)(4) STATING: "DURING ROBOTIC SURGERY, DA VINCI 5 (DV5) ROBOTIC SURGICAL SYSTEM THREW AN ERROR, SURGEON TRIED TO RECOVER THE ERROR. WHEN RECOVERED, WOULD NOT RETURN TO ITS NORMAL FUNCTIONALITY. THE DV5 STAT LINE WAS CALLED FOR TROUBLESHOOTING." ISI HAS RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. WHILE THE SYSTEM SAT IDLE FOR ABOUT 10 MINUTES WITH NO ACTION OR INTERACTION, THE TOWER ENCOUNTERED AN ERROR 17. THE FSE REVIEWED THE LOGS AND FOUND MULTIPLE ERRORS 48101, 32310, 32320, 307, AND 310 POINTING TO TOWER CORE COMMON COMPUTE CONTROLLER (CCC). THE FSE POWERED DOWN THE SYSTEM, CLEANED ALL BLUE FIBERS PLUGGED INTO TOWER CCC, REBOOTED, AND REVIEWED ERROR LOGS. THE FSE REPLACED THE VERTICAL ROLLING LOOP HARNESS AND CCC. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Additional Manufacturer Narrative · 0

    THE COMMON COMPUTE CONTROLLER (CCC) BOARD WAS RETURNED FOR ANALYSIS AND THERE WERE NO FUNCTIONAL ISSUES DETECTED WHEN INSTALLED ON AN IN-HOUSE SYSTEM. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A FAULTY ROLLING LOOP HARNESS IN THE CONSOLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A FAULT ON THE SYSTEM. THE CALLER STATED THE FAULT WAS CAUSING THE RIGHT MASTER TOOL MANIPULATOR (MTM) ON THE CONSOLE TO PULL OUT OF THE SURGEON'S HAND. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE ISSUE. THE TSE NOTICED THE SYSTEM HAD BEEN RUNNING FOR OVER 28 HOURS. THE TSE RECOMMENDED A HARD POWER CYCLE ON THE CONSOLE WHEN POSSIBLE. THE CALLER INFORMED THEY WOULD LET THE STAFF KNOW. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHEN THE FAULT OCCURRED ON THE SYSTEM, THE MTM YANKED FORWARD OUT OF THE SURGEON'S HAND. THE INSTRUMENT BEING CONTROLLED BY THE MTM STAYED IN PLACE. THE INSTRUMENT DID NOT JOLT FORWARD WITH THE MTM. THE SAME ISSUE OCCURRED INTERMITTENTLY THROUGHOUT THE CASE AND ONLY OCCURRED WITH THE ONE MTM. THE CUSTOMER INFORMED THAT SHE BELIEVED THIS ISSUE HAD OCCURRED IN THE PAST, BUT WAS UNABLE TO PROVIDE ANY ASSOCIATED DATES. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY INJURY OR HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480122 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES.