BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22025062 · Received May 15, 2025

    Report

    Report Number
    2955842-2025-20596
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 22, 2025
    Report Date
    April 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE VP WAS INSTALLED ONTO A GOLDEN SYSTEM (IS 4200) WHERE ERROR 319 WAS TRIGGERED BY INDICATING FAULT ON THE DWA BOARD, REPLICATING THE REPORT EVENT. THEN THE GOLDEN SYSTEM WAS SET TO RUN VIDEO TEST, 10 MINUTES SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED AND VERIFIED. THE DWA BOARD WAS THE SOURCE OF THE FAULT. AS A RESULT OF THIS FINDING, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE DWA BOARD IN THE VP WAS FOUND TO BE THE ROOT CAUSE OF ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE VIDEO PROCESSOR (VP). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) PRIOR TO STARTING THEY WERE FACING A NON-RECOVERABLE FAULT. THE TSE VIEWED THE SYSTEM EVENT LOGS AND NOTICED AN ERROR 319 POINTING THE VIDEO PROCESSOR (VP). THE TSE ASKED THEM TO SHUT DOWN THE SYSTEM AND CHECK THE POWER SWITCH AT THE BACK SIDE OF THE VP. THE TSE ASKED THEM TO CHECK THE POWER CORD AT THE BACK SIDE OF THE VP. AFTER RESTARTING, THE ERROR REMAINED. THE SYSTEM WAS DOWN. THE CUSTOMER STATED THAT THE OTHER VISION SIDE CART WERE NOT AT THE SAME SITE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825185 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

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