BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 25157251 · Received May 13, 2026

    Report

    Report Number
    2955842-2026-24841
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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. THE FSE FOUND THE SYSTEM POWERED ON WITH ONLY THE CONSOLE BLUE FIBER CABLE (BFC) CONNECTED TO THE VISION SIDE CART (VSC) AND THAT CABLE PLUGGED INTO THE BOTTOM TOWER PORT. THE FSE POWERED THE SYSTEM OFF, RECONFIGURED THE BFC SO THE CONSOLE BFC WAS IN THE TOP LEFT PORT WITH THE ADJACENT TOP RIGHT PORT EMPTY, AND THEN POWERED THE SYSTEM ON, AT WHICH POINT ERROR 31089 OCCURRED ONCE AND WAS RECOVERED, ALLOWING THE SYSTEM TO COMPLETE THE POWER-ON SEQUENCE WITHOUT REPEATING THE ERROR. THE FSE THEN PERFORMED MULTIPLE POWER CYCLES WITHOUT RECURRENCE, CHANGED THE BFC PORT CONFIGURATION AGAIN BY MOVING THE PATIENT SIDE CART (PSC) BFC TO THE TOP RIGHT PORT AND LEAVING THE BOTTOM PORT EMPTY, AND REPEATED MULTIPLE POWER CYCLES WITH NO FURTHER ERRORS. THE FSE PROACTIVELY REPLACED THE PSC COMMON COMPUTE CONTROLLER (CCC) BASED ON PRIOR INFORMATION THAT ERROR 170 POINTED TO THE PATIENT CART CONTROLLER (PCC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 170 OCCURRED ON THE SYSTEM. THE TSE FOUND ERRORS 31089 IN THE LOGS POINTING TO VISION SIDE CART (VSC) FIBER 3 AND 307 POINTING TO PATIENT CART CONTROLLER (PCC) 3. CUSTOMER HAD POWER CYCLED THE SYSTEM TWICE PRIOR TO CONTACTING THE TSE WITH NO CHANGE. THE TSE HAD THE CUSTOMER PERFORM A HARD POWER CYCLE AND RESEATED THE BLUE FIBER CABLES ON THE SYSTEM AND THE ERROR CLEARED AT THE TIME. AFTER, THE CUSTOMER CALLED BACK TO REPORT THAT THE ERROR WAS RETURNED. THE CUSTOMER PLANNED TO USE A DIFFERENT SYSTEM TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306848 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1