BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23426919 · Received October 30, 2025

    Report

    Report Number
    2955842-2025-43006
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE AXES CONTROLLER PLATFORM DUAL (ACPD) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS CONFIRMED, BUT NOT REPLICATED. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE HOUSING OF J10 CONNECT WAS BROKEN OFF. FAILURE ANALYSIS WAS NOT ABLE TO INSTALL THIS BOARD INTO A TEST SYSTEM TO VERIFY THE REPORT ERROR 32100 BECAUSE THE PIN OF HOUSING OF J10 CONNECT WAS BROKEN OFF.

    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 COULD NOT REPRODUCE THE ERROR. THE FSE REPLACED THE AXES CONTROLLER PLATFORM (ACP) FOR THE WRIST, AND UPON TESTING, WAS ABLE TO REPRODUCE 32100 FAULTS CONSISTENTLY WHEN MANIPULATING THE WRIST BRAKE PLUG AT THE J10 CONNECTION ON THE AXES CONTROLLER PLATFORM DUAL (ACPD). THE PLUG CONTACTS WERE FOUND TO BE OPENED UP DURING RESISTANCE TESTING AND WERE NOT MAKING GOOD CONTACT WITH J10. THE FSE TIGHTENED THE BRAKE PLUG CONTACTS AND FOUND J10 ON THE ACPD TO BE LOOSE, SO THE ACPD WAS REPLACED. AFTER PART REPLACEMENTS AND ADJUSTMENT OF PLUG CONTACTS, THE 32100 FAULTS COULD NO LONGER BE REPRODUCED WHEN WIGGLING THE BRAKE PLUG. THE BRAKES WERE PULSED AND THE OP WRIST WAS DRIVEN THROUGH ITS FULL RANGE OF MOTION MULTIPLE TIMES, WITH THE ROBOT LEFT POWERED ON WHILE OTHER WORKFLOWS WERE PERFORMED. NO FURTHER 32100 FAULTS OCCURRED AND THE SYSTEM WAS FUNCTIONING NORMALLY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ACP WAS ANALYZED AND THE REPORTED ERROR 32100 WAS CONFIRMED BUT NOT REPLICATED. IN ARTEMIS, THIS ERROR 32100 WAS FOUND INDICATING A SYSTEM FAULT, AND CONFIRMING THE FAULT DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS UNIT WAS INSTALLED, PROGRAMMED, AND TESTED ON THE PCA GOLD SYSTEM; POWER CYCLED 10 TIMES WITH NO ISSUE ON STARTUP AND NO ERRORS OR FAILURES WERE TRIGGERED. THIS UNIT REMAINED ON THE SYSTEM FOR 4 HOUR IDLING IN NORMAL MODE WITH NO ISSUE. IN ADDITION TO THE TEST, THIS UNIT WENT THROUGH IN PROCESS CORRECTION VERIFICATION AND PASSED ALL THE TESTS. AS A RESULT OF THIS TEST, AND FINDINGS, FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO REPORTED EVENTS. ADDITIONALLY, THIS UNIT WAS RETURNED ALONG WITH ACPD FOR THE SAME REPORTED EVENT. FA IS IN PROGRESS.

    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 SURGICAL PROCEDURE, THE SYSTEM HAD NON-RECOVERABLE ERRORS. THE CUSTOMER ATTEMPTED MULTIPLE POWER CYCLES, BUT THE ISSUE PERSISTED. THE SYSTEM LOGS CONFIRMED REPEATED ERRORS REPORTED BY AXES CONTROLLER PLATFORM (ACP) 5, WITH A DIAGNOSIS INDICATING ERRORS FOR BOOM AND A FAILING WRIST BRAKE. THE CUSTOMER INITIALLY PLANNED TO REPLACE THE ROBOT WITH ONE FROM ANOTHER DA VINCI 5 SYSTEM, BUT LATER REPORTED NO AVAILABLE DA VINCI 5 SYSTEMS AND DECIDED TO SWITCH TO A DA VINCI XI SYSTEM TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM AFTER THE PORTS HAD BEEN PLACED PRIOR TO DOCKING. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THEIR DA VINCI XI SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602599 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 N/A 00886874119716

    Patients

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