BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 22828879 · Received August 18, 2025

    Report

    Report Number
    2955842-2025-34626
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 22, 2025
    Report Date
    July 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPLACED USM #1 TO RESOLVE THE NON-RECOVERABLE FAULT ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE USM HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H3, H6, AND H11 DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE LOGS, AN ERROR WAS FOUND INDICATING A FAULTY MOTOR, ENCODER, AMPLIFIER, OR CONNECTION ON THE USM, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, SIGNS OF HEAVY FLUID INTRUSION WERE FOUND ON THE USM THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A KNOWN WORKING SYSTEM WHERE THE ERROR WAS TRIGGERED INDICATING FAULT ON THE AXES CONTROLLER CARRIAGE POWER (ACCP) CIRCUIT BOARD AND CARRIAGE MOTOR STATOR, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE ACCP CIRCUIT BOARD AND CARRIAGE MOTOR STATOR WERE INSPECTED AND WERE VERIFIED TO BE THE SOURCE OF THE FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A NON-RECOVERABLE ERROR OCCURRED WHILE DOCKING. AT THE TIME THE ISSUE OCCURRED, ANESTHESIA HAD ALREADY BEEN ADMINISTERED TO THE PATIENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS AND IDENTIFIED THE ERROR POINTING TO UNIVERSAL SURGICAL MANIPULATOR (USM) #1. THE TSE INSTRUCTED THE NURSE TO REBOOT THE SYSTEM, BUT THE ERROR RETURNED. THE SURGEON TOOK OVER AND THE TSE ADVISED REMOVING THE INSTRUMENT AND STERILE ADAPTER, EXERCISING THE WHEEL OF AXIS 4 ON THE CARRIAGE, RESEATING THE STERILE ADAPTER, AND PERFORMING A HARD POWER RESET WITH EMERGENCY POWER-OFF (EPO). THE CUSTOMER STATED THE OPERATION HAD TO BE ABORTED AS THE ERROR COULD NOT BE RECTIFIED DESPITE TELEPHONE SUPPORT WITH THE TSE. THE SURGEON EXPLAINED THAT THE PROCEDURE COULD NOT BE PERFORMED WITH ONLY 3 USMS. THE PATIENT OPTED TO NOT SCHEDULE ANOTHER SURGERY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589922 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-39 N/A 00886874115404

    Patients

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