BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25052484 · Received April 30, 2026

    Report

    Report Number
    2955842-2026-23386
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE MTM HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT VIA SYSTEM LOGS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS INSTALLED ONTO THE SURGEON SIDE CONSOLE FIXTURE TEST PLATFORM (SFTP) WHERE SINE CYCLE TEST WAS FOUND TO BE FAILING ON THE GIMBAL, REPLICATING THE REPORTED EVENT. ONCE TESTING WAS COMPLETED, THE EMBEDDED SERIALIZER FOR MASTER HANDLE (ESMH) PRINTED CIRCUIT ASSEMBLY (PCA) WAS (APPLIED BEHAVIOR ANALYSIS) ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. AS A RESULT OF THIS INVESTIGATION, FA HAS CONCLUDED THAT THE ESMH PCA WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO SENSOR-RELATED ELECTRONIC COMPONENT DEFECT OF THE ESMH PCA IN THE MTM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE RIGHT MASTER TOOL MANIPULATOR (MTM) STOPPED RESPONDING RESULTING IN THE SURGEON NOT BEING ABLE TO MOVE THE UNIVERSAL SURGICAL MANIPULATORS 3 AND 4. THE CUSTOMER POWER CYCLED THE SYSTEM, BUT THE ISSUE REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER ADVISED THE CUSTOMER TO SWAP OUT THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER SWAPPED THE SSC AND RESOLVED THE ISSUE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE DID NOT PRODUCE AN ERROR DURING THE CASE AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225344 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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