BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 25192035 · Received May 15, 2026

    Report

    Report Number
    2955842-2026-25435
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 15, 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
    GA, US
    Reporter Occupation
    003

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED THE FIBER OPTIC CABLE AND AXES CONTROLLER PLATFORM (ACP) BOARD TO RESOLVE THE ISSUE. THE FSE LATER RETURNED TO SWAP OUT THE SYSTEM COMPLETELY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE CFG, ACP WAS RECEIVED AND UNDERWENT INVESTIGATION. THE REPORTED ERRORS WERE CONFIRMED, BUT NOT REPLICATED. UPON VISUAL INSPECTION, THERE WERE NO ISSUES FOUND RELATED TO THE REPORTED EVENT. THE UNIT WAS TESTED ON A GOLDEN UNIT AND FUNCTIONED AS EXPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SITE EXPERIENCED AN ERROR POINTING TO THE AXES CONTROLLER PLATFORM (ACP) ON THEIR SYSTEM, WITH COMMUNICATION ERRORS ON THE ROBOT. THE TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE SITE TO PERFORM A HARD POWER CYCLE AND RESEAT THE FIBER CONNECTIONS ON THE ROBOT AND TOWER, WHICH CLEARED THE ISSUE. TSE HAD THE SITE MOVE THE ARMS, BOOM, AND DRIVE THE ROBOT, CONFIRMING NO FURTHER ERRORS. THE SITE CONTINUED WITH SETUP AND PROCEDURE START. WHILE THE PROCEDURE WAS IN PROGRESS, THE SYSTEM FAULTS RETURNED REQUIRING MULTIPLE SYSTEM RESTARTS. THE CUSTOMER ELECTED TO CONVERT THE SURGERY TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330806 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1