BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25038448 · Received April 29, 2026

    Report

    Report Number
    2955842-2026-23238
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF THE DATE OF THIS REPORT, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED TABLE MOTION (ITM) HAD UNPAIRED FROM THE SYSTEM MID PROCEDURE AND CREATED A RECOVERABLE FAULT. THIS LED TO THE CONSOLE SURGEON LOSING CONTROL OF THE INSTRUMENTS AND THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS STILL MOVING INSIDE THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT. THE ASSISTANT MOVED THE UTERUS TO AVOID THE MCS FROM CONTACTING IT. AFTER THIS THEY WERE ABLE TO RECOVER THE FAULT AND CONTINUE THE PROCEDURE, BUT THE TABLE DID NOT PAIR AND FUNCTION DURING OR AFTER THE PROCEDURE EVEN THOUGH THE SYSTEM WAS UNDOCKED. AFTER THIS, THEY RESTARTED THE SYSTEM, THE TABLE PAIRED AND RESTORED FUNCTIONALITY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO HARM WAS CAUSED WHEN THE UTERUS WAS MOVED TO AVOID CONTACT WITH THE MCS INSTRUMENT DURING THE PROCEDURE. THE SURGEON EXPERIENCED A MOTION ISSUE WHEN THE CONNECTION WITH ITM WAS LOST: THE INSTRUMENT DID NOT RESPOND TO COMMANDS AT ALL, AND THEN THE CONTROLLERS BEGAN DRIFTING ON THEIR OWN, RESULTING IN UNCONTROLLED MOTION. NURSES OBSERVED THAT THE TIP OF THE MCS MOVED A FEW CENTIMETERS AFTER THE CONNECTION WAS LOST. THIS ISSUE OCCURRED WHILE THE SURGEON'S HEAD WAS INSIDE THE SURGEON CONSOLE. THE SURGEON INITIALLY DID NOT REMOVE THEIR HANDS FROM THE CONTROLS WHEN THE CONNECTION WAS LOST BUT HAD TO DO SO WHEN THE CONTROLLERS STARTED DRIFTING. THE PROBLEM WAS RESOLVED DURING THE PROCEDURE BY CHECKING OFF THE ERROR FROM THE VISION CART, ALTHOUGH THE ITM ISSUE PERSISTED UNTIL A FULL RESET WAS PERFORMED. THE MCS INSTRUMENT IS AVAILABLE FOR RETURN; THE CUSTOMER ASKED ABOUT THE PROCESS AND HAS SINCE USED THE INSTRUMENT WITHOUT FURTHER PROBLEMS. THERE IS A VIDEO RECORDING OF THE PROCEDURE, AND THE CUSTOMER IS INQUIRING ABOUT GRANTING INTUITIVE SURGICAL ACCESS TO THIS FOOTAGE. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230603 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K11250130 0173 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1