BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 24775993 · Received April 3, 2026

    Report

    Report Number
    2955842-2026-20040
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 3, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WAS ABLE TO REPLICATE THE ERROR ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3, AND THE USM WAS REPLACED TO CORRECT THE REPORTED PROBLEM. THE REPLACEMENT USM3 AND SYSTEM WERE TESTED AND VERIFIED AS READY FOR USE. THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS RETURNED FOR FAILURE ANALYSIS (FA), AND THE REPORTED SYSTEM ERROR WAS CONFIRMED AND REPLICATED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED NODE CHECK. FIRST, THE ROLLING LOOP FIBER WAS BYPASSED AND THE AXES CONTROLLER, CARRIAGE LOGIC (ACCL) BOARD WAS REPLACED BUT THIS DID NOT FIX THE ISSUE. AFTER THE AXES CONTROLLER, CARRIAGE POWER (ACCP) BOARD WAS REPLACED THE MISSING NODE ERROR WAS NO LONGER TRIGGERED. WHEN THE ORIGINAL ACCP BOARD WAS INSTALLED AGAIN, THE ERROR RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) 3 EXPERIENCED REPEATED SYSTEM ERRORS. THE SITE ATTEMPTED 3 SYSTEM RESTARTS, BUT THE ERROR PERSISTED. INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED THE CUSTOMER PERFORM A HARD POWER CYCLE, BUT THE ISSUE REMAINED. TSE ASKED IF THE PROCEDURE COULD BE COMPLETED WITH 3 USMS, BUT THE SURGEON STATED THEY WOULD NEED ALL 4 USMS. ADDITIONALLY, THE SITE REPORTED USM 3 WOULD NOT DISABLE, AND THE PATIENT SIDE CART (PSC) WAS ONLY ABLE TO BE MOVED IN MANUAL MODE. IT WAS STATED THERE WERE NO BACKUP INTUITIVE SYSTEMS AVAILABLE RESULTING IN THE PROCEDURE BEING CONVERTED TO OPEN AFTER PORTS HAD BEEN PLACED. THE PATIENT TOLERATED THE CONVERSION WITH NO INJURIES OR POST-OPERATIVE COMPLICATIONS REPORTED. THE PATIENT HAS BEEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575717 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1