BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25030059 · Received April 29, 2026

    Report

    Report Number
    2955842-2026-23210
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 21, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE DISTAL SET-UP JOINT AND THE E-CHAIN SETUP STRUCTURE (SUS) FOR FAILURE ANALYSIS INVESTIGATION. THE UNITS WERE ANALYZED AND INVESTIGATIONS WERE OBTAINED: DSUJ: THE UNIT WAS ANALYZED AND NO ERROR WAS FOUND ON THE SUJ DISTAL IN QUESTION. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON A GOLDEN SYSTEM IN NORMAL MODE WHERE IT TRIGGERED ERROR 319 AT STARTUP INDICATING NODE DOES NOT PRESENT THUS CONFIRMING AND REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE NODES B AND C WERE MISSING DURING PROGRAMMING. INSTALL GOLDEN SFL BUT STILL FAILED NODE CHECK. INSTALLED GOLDEN ACT, ABA TEST AND VERIFIED IT TO BE THE SOURCE OF THE FAULT. E-CHAIN: THE UNIT WAS ANALYZED AND NO ISSUE WAS FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THERE IS NO PROCESS TO CARRY OUT THE TEST. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE BASED ON ELECTRICAL AND FIBEROPTIC DEFECTS.

    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 CARDCAGE. THE SYSTEM WAS VERIFIED AND READY FOR USE. THE UNIT WAS ANALYZED AND THEN INSTALLED ONTO THE GOLDEN SYSTEM, WHERE THE CARDCAGE WAS NOT ABLE TO PROGRAM, AND THE PSC TAB WAS NOT DISPLAYED IN THE DOWNLOAD APP, INDICATING THAT COMMUNICATION WITH THE ENTIRE PSC WAS LOST. THE UPD, UCC, UMC 1, AND UMC 2 BOARDS WERE SWAPPED WITH GOLDEN BOARDS ON THE GOLDEN CARDCAGE, BUT THE PROBLEM STILL PERSISTED. THE FAILED CARDCAGE WAS THEN SWAPPED WITH THE GOLDEN ONE, AND EVERYTHING RETURNED TO NORMAL. THE FAILURE ANALYSIS TEAM THEN SWAPPED THE UNIVERSAL POWER DISTRIBUTOR (UPD), UC UMC 1, AND UMC 2 BOARDS FROM THE FAILED CARDCAGE INTO THE GOLDEN CARDCAGE, AND IT FUNCTIONED AS EXPECTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE PATIENT CART AND TOWER WERE NOT COMMUNICATING. LOGS INDICATED THE PATIENT CART WAS NOT BEING RECOGNIZED. TSE WALKED THE CALLER THROUGH MULTIPLE HARD POWER CYCLES AND SWAPPED OUT THE BLUE FIBER CABLE TO THE PATIENT CART WITH NO CHANGE. THE PATIENT CART POWER BUTTON WOULD BEGIN FLASHING BLUE IMMEDIATELY AFTER THE HARD POWER CYCLE EVEN WHEN THE VISION TOWER WAS OFF AND LOCATED A SPARE BLUE FIBER CABLE AND AFTER SWAPPING IT OUT THERE WAS STILL NO CHANGE. CALLER LOCATED A BACKUP PATIENT FROM ANOTHER SYSTEM THAT WAS NOT IN USE AND AFTER SWAPPING IT OUT THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207789 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1