BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21601811 · Received March 13, 2025

    Report

    Report Number
    2955842-2025-07721
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 14, 2025
    Report Date
    February 14, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY REBOOTING THE SYSTEM. THE FSE NOTED THAT THE ISSUE COULD BE RELATED TO USER SETTING, AND AFTER A SYSTEM REBOOT, IT ALLOWED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO REORIENT ITS LOCATION IN RELATION TO THE REMOTE CENTER. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. A REVIEW OF THE SUBMITTED VIDEO WAS PERFORMED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: UNFORTUNATELY WITHOUT SIMULTANEOUS VIDEO OF THE MASTER TOOL MANIPULATORS (MTMS) AT THE SURGEON CONSOLE, I CAN'T SAY FOR CERTAIN WHAT COULD BE GOING ON OR DETERMINE A ROOT CAUSE. THE MOTION APPEARS TO HAVE A MORE REGULAR CADENCE THAN I WOULD EXPECT TO SEE WITH TRUE UNINTUITIVE MOTION, BUT AGAIN, FROM THIS VIDEO ALONE I CAN'T PROVIDE MUCH ELSE. .

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE CUSTOMER CALLED TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT ONE OF THE ARMS WAS MOVING ON ITS OWN. A FIELD SERVICE ENGINEER REACHED OUT TO THE CUSTOMER SALES REPRESENTATIVE (CSR) TO INFER THAT THE ISSUE PROBABLY OCCURRED BECAUSE WHILE WORKING IN A TIGHT SPACE CLOSE TO THE CANNULA THE INSTRUMENT ENCOUNTERED RESISTANCE WHILE SIMULTANEOUSLY THE MASTER TOOL MANIPULATOR (MTM) EXPERIENCED FORCE, RESULTING IN THE USM TRYING TO CYCLE BACK TO THE CORRECT POSITION. REBOOTING THE SYSTEM ALLOWED THE ARMS TO REORIENT ITSELF IN RELATION TO THE REMOTE CENTER. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTIN WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON FSE NOTES AND TECHNICAL REVIEW THE ISSUE IS PROBABLE DUE TO AN ORIENTATION ISSUE OF THE ARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE VESSEL SMALL THORACOTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ONE OF THE UNIVERSAL SURGICAL MANIPULATORS (USM) WAS MOVING/BOUNCING ON ITS OWN. THE USER PERFORMED A SYSTEM REBOOT, WHICH SUCCESSFULLY RESOLVED THE ISSUE. THE TSE REVIEWED THE SYSTEM ERROR LOGS BUT FOUND NO RELATED ERRORS EXCEPT A MID-PROCEDURE RESTART. THE TSE ASKED IF THE SURGEON'S HEAD WAS INSIDE THE SURGEON SIDE CONSOLE AND IF THEY REMOVED THEIR HANDS FROM THE MASTER TOOL MANIPULATORS (MTM) WHEN THE ISSUE OCCURRED BUT THE USER DID NOT THINK SO. THE USER CONTINUED WITH THE PROCEDURE USING THE SAME SYSTEM CONFIGURATION WITHOUT FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985794 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A

    Patients

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