BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21689246 · Received March 25, 2025

    Report

    Report Number
    2955842-2025-09392
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    February 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 24-MAR-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING THE SYSTEM ON AND NO ISSUES OR ERRORS WERE NOTED. THERE WAS A SEVERE ADHESION, AND THE CUSTOMER CONVERTED TO LAPAROTOMY INSTEAD. NO ADDITIONAL PORTS WERE PLACED OR INCREASED. THE PROCEDURE WAS CONVERTED, AND THE PATIENT TOLERATED THE CHANGE. THERE WAS NO INJURY TO THE PATIENT. NO PATIENT INFORMATION WAS AVAILABLE.

    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 WENT ON SITE AND REPLACED THE SET UP JOINT (SUJ) DUE TO CUSTOMER REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE SUJ TO PERFORM FAILURE ANALYSIS. THE SUJ WAS ANALYZED AND ONE OF THE ERRORS WAS CONFIRMED. A REVIEW OF THE LOGS CONFIRMED BOTH ERRORS IDENTIFIED DURING THE EVENT. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHICH DID NOT TRIGGER ANY ERRORS AT STARTUP IN NORMAL MODE. THE SYSTEM WAS LEFT RUNNING FOR A WHILE AND THEN REBOOTED. THE INITIAL ERROR WAS TRIGGERED WHEN EXERCISED AND THE SECOND ERROR WAS TRIGGERED AFTER THE INITIAL ERROR WAS CLEARED. THE UNIT WAS THEN INSTALLED ONTO A TEST PLATFORM AND THE UNIT PASSED ALL APPLICABLE TEST. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE AXES CONTROLLER TORNADO (ACT) PRINTED CIRCUIT ASSEMBLY (PCA), LOW VOLTAGE DIFFERENTIAL SIGNALING (LVDS) AND ENCODER HARNESSES AND SETUP FRU LOWER (SFL) PCA ARE CONSISTENT WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, TWO SEPARATE ERRORS OCCURRED ON THE UNIVERSAL SURGICAL MANIPULATOR #4 (USM). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CUSTOMER TO PERFORM A POWER CYCLE, BUT ONE OF THE ERRORS REOCCURRED ON USM 4. THE TSE ADVISED TO UNINSTALL ALL INSTRUMENTS. HOWEVER, THE CUSTOMER MENTIONED THAT THEY COULD NOT UNINSTALL THE INSTRUMENT FROM THE USM #4. THE TSE THEN ADVISED THE CUSTOMER TO UNINSTALL USM #4 WITH THE PORT. FOR AN UNSPECIFIED REASON, THE CUSTOMER WAS UNABLE TO UNINSTALL IT. THE CUSTOMER PERFORMED A HARD POWER CYCLE OF THE PATIENT SITE CART (PSC) AND EMERGENCY POWER OFF (EPO) BUT THE ERROR PERSISTED. AS A RESULT, THE SURGEON DECIDED TO CONVERT THE CASE TO OPEN SURGERY WHICH WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093616 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

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