BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI XI

    MDR report key: 21797902 · Received April 8, 2025

    Report

    Report Number
    2955842-2025-13692
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 19, 2025
    Report Date
    March 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED SYSTEM COMPONENT(S) TO RESOLVE THE REPORTED ISSUE. THE MASTER TOOL MANIPULATOR (MTM) HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. THE MTM WAS ANALYZED AND FOUND TO HAVE AN ERROR IN THE LOGS; THE ERROR WAS FOUND RELATING TO THE MASTER JUNCTION BOARD CONNECTIONS IN GIMBAL (MJB), EMBEDDED SERIALIZER IN MASTER BASE (ESMB), EMBEDDED SERIALIZE IN MASTER PLATFORM (ESMP), EMBEDDED SERIALIZE IN MASTER YAW (ESMP) CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE MTM WAS THEN INSTALLED ONTO A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION.

    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 MASTER TOOL MANIPULATOR (MTM) TO RESOLVE THE ISSUE WITH ERRORS ON THE LEFT MTM (MTML). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITH LYMPHADENECTOMY) SURGICAL PROCEDURE, THE USER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ENCOUNTERED REPEATED ERRORS FROM THE LEFT MASTER TOOL MANIPULATOR (MTML). THE TSE REVIEWED THE SYSTEM ERROR LOGS AND CONFIRMED THE OCCURRENCE OF THE ERROR. THE USER REBOOTED THE SYSTEM TWICE WITHOUT SUCCESS, BUT THE ERROR CLEARED ON THE THIRD ATTEMPT. THE USER ABORTED THE PROCEDURE DUE TO THE MTML ISSUE. A PROCEDURE DELAY WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE PROCEDURE WAS ABORTED DUE TO THE REPEATED ERROR ON THE LEFT MASTER TOOL MANIPULATOR (MTML). THE MTML WAS REPLACED ON THE FOLLOWING DAY AND THE PROCEDURE WAS LATER COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753511 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-07 N/A

    Patients

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