BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22352957 · Received June 30, 2025

    Report

    Report Number
    2955842-2025-27905
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 4, 2025
    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
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE SET UP JOINT (SUJ) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC., (ISI) DID RECEIVE THE PROXIMAL SET-UP JOINT (PSUJ) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PSUJ WAS ANALYZED AND REPORTED FAILURE WAS CONFIRMED. SYSTEM LOGS SHOWED ERROR 31226 INDICATING THAT AN AURORA LINK ERROR HAD OCCURRED ON SUJ1. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE ERROR 40067 WAS TRIGGERED AND IT WAS A NON-RECOVERABLE FAULT. THE UNIT WAS THEN INSTALLED ONTO A PFTP WHERE IT FAILED FIBER POWER TEST. A GOLDEN FIBER OPTIC CABLE WAS INSTALLED AND IT PASSED ALL APPLICABLE TESTING. THE ORIGINAL FIBER OPTIC CABLE WAS REINSTALLED AND IT FAILED THE FIBER POWER TEST AGAIN, REPLICATING THE REPORTED EVENT. THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE CAN BE ATTRIBUTED TO A FAULT OF THE FIBER OPTIC CABLE WITHIN THE AFFECTED SUJ.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL RECTOPEXY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THE SYSTEM EXPERIENCED A NON-RECOVERABLE FAULT. TSE NOTED FAULTS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM NET 1. TSE HAD THE CUSTOMER REBOOT THE SYSTEM TO RESOLVE. TSE INFORMED THE CUSTOMER THAT THE FAULT COULD RETURN. THE CUSTOMER REQUESTED INFORMATION ON HOW TO DISABLE ARM 1. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850495 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36 N/A 00886874110720

    Patients

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