BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22463002 · Received July 9, 2025

    Report

    Report Number
    2955842-2025-29247
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 18, 2025
    Report Date
    June 18, 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
    CH
    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 EVENT. THE FSE WENT ON-SITE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN THE SYSTEM LOGS, THE ERRORS 307 AND 319 WERE FOUND INDICATING FAULT ON THE "AXES CONTROLLER SPAR (ACS) PRINTED CIRCUIT ASSEMBLY (PCA)¿, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE ACS BOARD WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO A TRANSIENT COMMUNICATION FAILURE INVOLVING THE ACS BOARD LOCATED IN THE USM. THIS ISSUE CAN BE RESOLVED BY REPLACING THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE TRANSABDOMINAL PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE DA VINCI SURGERY TECHNICAL ASSISTANCE TEAM (DVSTAT) AND REPORTED THAT ERROR 307 AND 319 OCCURRED AFTER THE SYSTEM WAS POWERED ON. THE SITE ATTEMPTED TO RESOLVE THE ISSUE BY POWER CYCLING THE SYSTEM, BUT THE PROBLEM PERSISTED. AS A RESULT, THE SITE DECIDED TO DISABLE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AND COMPLETE THE PROCEDURE USING THE OTHER THREE ARMS. THE PROCEDURE CONTINUED AS PLANNED. THE TECHNICAL SUPPORT ENGINEER (TSE) GOT THE ERROR LOGS AND FOUND ERRORS 307 AND 319 POINTING TO USM 1'S AXES CONTROLLER SPAR (ACS) AND AXES CONTROLLER CARRIAGE (ACC) ISSUES. THE FIELD SERVICE ENGINEER (FSE) WOULD FOLLOW UP ON THE ISSUE. 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
    161537 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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