BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24614409 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-16384
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 19, 2026
    Report Date
    May 5, 2026
    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
    WY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL ANNEX G CODE ADDED AFTER QUALITY ENGINEER REVIEW. THE ROOT CAUSE OF THE GRIP STICKING IS DUE TO DAMAGED GRIP SPRINGS ON THE MTM. THIS CAN BE RESOLVED BY CONTACTING ISI AND HAVING THE FSE SERVICE THE SYSTEM.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MASTER TOOL MANIPULATOR (MTM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ISSUE OF THE "RIGHT HAND CONTROL BEING STICKY AND LAGGY; THE RIGHT HAND HAS TO BE FORCED OPEN" WAS CONFIRMED AND REPLICATED. IN LIGHTHOUSE, THERE WERE NO ERRORS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE GRIP SPRING WAS FOUND TO BE DAMAGED, REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ONTO AN SFTP FOR A FITNESS TEST AND FAILED THE GRIP TORQUE MARGIN VERIFICATION POST SINE CYCLE (SPRING CONSTANT, SPRING OFFSET, TORQUE MARGIN, AND OPEN POSITION) AND GRAVITY BALANCE TEST POST SINE CYCLE (GRIP MAX IMBALANCE AND GRIP MIN FRICTION), REPLICATING THE EVENT. ADDITIONAL FINDINGS INCLUDED GRAVITY BALANCE TEST POST SINE - WP (WRIST PITCH MIN MARGIN AND WRIST PITCH MIN FRICTION), GRAVITY BALANCE TEST POST SINE CYCLE - EL (ELBOW MAX IMBALANCE), GRAVITY BALANCE TEST POST SINE - SH (SHOULDER MAX IMBALANCE), AND GRAVITY BALANCE TEST POST SINE CYCLE - WY (WRIST YAW MIN MARGIN), WHICH WERE CLEARED AFTER RECALIBRATION AND ADDING GREASE TO WRIST PITCH GEARS. THE GIMBAL NEEDS TO HAVE THE "4W" FFC MARK AND FOLD CHANGED PER GIMBAL REPAIR TRAVELER 13548-0. AS A RESULT OF THIS INVESTIGATION, FAILURE ANALYSIS HAS CONCLUDED THAT THE GRIP SPRING WAS THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT SEVERAL DOCTORS HAD COMPLAINED ABOUT THE RIGHT HAND CONTROL BEING STICKY AND LAGGY. THE CALLER DESCRIBED THE BEHAVIOR AT REST AS THE LEFT HAND JAWS BEING OPEN NATURALLY, BUT THE RIGHT HAND HAD TO BE FORCED OPEN. THE TECHNICAL SUPPORT ENGINEER REVIEWED THE LOGS BUT FOUND NO RELATED ISSUE. THE CALLER REQUESTED A FIELD ENGINEER TO EXAMINE THE SYSTEM AS THE SURGEON REFUSED TO USE IT AGAIN UNTIL IT WAS INSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606846 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1