BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24880772 · Received April 15, 2026

    Report

    Report Number
    2955842-2026-21549
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 15, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 WENT ON-SITE AND REPLACED THE DISTAL SET-UP JOINT (DSUJ). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE DISTAL SET-UP JOINT (DSUJ) FOR FAILURE ANALYSIS INVESTIGATION. THE DSUJ WAS ANALYZED AND ERRORS 23070 AND 23071 WERE FOUND INDICATING PRIMARY AND SECONDARY SETUP JOINT OUTSIDE OF LIMITS ON THE SUJ DISTAL POINTING TO THE WRIST THUS CONFIRMING THAT THE FAULTS OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM IN NORMA MODE WHERE IT FUNCTIONED AS EXPECTED. THE UNIT WAS ALSO INSTALLED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT PASSED ALL RELEVANT TESTS WITH NO LOG ERRORS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE BASED ON ELECTRICAL AND FIBEROPTIC DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 2 REPEATEDLY FAULTED. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERROR 23070 AGAINST THE DISTAL SET-UP JOINT OF USM 2. THE CALLER POWER CYCLED THE SYSTEM AND THE FAULT CAME BACK. THE TSE HARD POWER CYCLED THE PATIENT SIDE CART (PSC) AND THE FAULT CAME BACK AGAIN AT POWER UP. THE CALLER TRIED TO RECOVER THE FAULT, BUT THE FAULT CAME BACK IMMEDIATELY. THE TSE ASKED IF THE CUSTOMER NEEDED ALL FOUR USMS FOR THE CASE, WHICH THEY DID. THE CALLER STATED THEY WOULD LIKELY CANCEL THE CASE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389482 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1