BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21660745 · Received March 21, 2025

    Report

    Report Number
    2955842-2025-10179
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 24, 2025
    Report Date
    February 24, 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
    TX, 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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE USM TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT. SYSTEM LOGS FOUND ERROR 319 INDICATING A NODE NOT PRESENT AT START UP ON AXES CONTROLLER CARRIAGE (ACC), CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE ROLLING LOOP FIBER WAS MISALIGNED AND BEING SNAGGED DURING CARRIAGE MOVEMENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERROR 319 WAS TRIGGERED INDICATING FAULT ON THE ACC BOARD, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE CHECK ALL BOARDS WERE FOUND TO BE FAILING ON ACC BOARD. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. AS A RESULT OF THESE FINDINGS, FA WAS ABLE TO CONCLUDE THAT THE ROLLING LOOP FIBER WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SITE INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT REPEATED NON-RECOVERABLE ERROR 319 OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) #1. SITE PERFORMED POWER CYCLE THE PATIENT SIDE CART (PSC) WITH EMERGENCY POWER OFF (EPO) SEVERAL TIMES, BUT THE ERROR WAS NOT RESOLVED. AFTER SITE DISABLED USM #1, THE SYSTEM WAS ABLE TO COMPLETE SELF-TEST AND READY FOR USE. HOWEVER, THE SURGEON NEEDED ALL FOUR USM ARMS FOR THE PROCEDURE; THEREFORE, THE SURGEON OPTED TO USE ANOTHER PATIENT SIDE CART TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308233 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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