BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694492 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18152
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 3, 2025
    Report Date
    March 25, 2026
    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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. FSE REPLACED THE PATIENT SIDE CART (PSC) COMPUTE ENGINE [PCE], AXES CONTROLLER PLATFORM DUAL (ACPD) AND AXIS MOTOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PCE WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS (FA). IN LIGHTHOUSE, NO DATA NOR ERROR LOGS THAT THIS FAILURE DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS PSC PCE CFG WAS INSTALLED, PROGRAMMED AND TESTED ON THE DV5 IN HOUSE GOLDEN SYSTEM AT LOCATION PCE 5 SLOT OF THE PSC CARDCAGE WITH NO ISSUE, NO ERRORS TRIGGERED ON STARTUP. RUN MULTIPLE POWER CYCLES WITH NO FAILURES AND NO ERRORS TRIGGERED. THIS UNIT WAS IDLING FOR 1 HOUR IN NORMAL MODE, WITH NO ISSUES AND NO ERRORS TRIGGERED. ADDITIONAL TESTS WERE PERFORMED TO VERIFY THE PSC BOOM FUNCTIONS, SET UP STRUCTURE (SUS) BOOM COLUMN - AXIS 0, SUS BOOM SHOULDER - AXIS 1, SUS BOOM AXIS 2, AND SUS BOOM WRIST - AXIS 3 AND ALL TEST PASSED. THE ACPD WAS ANALYZED AND THE COMPLAINT WAS CONFIRMED BY FA. CHECKED SYSTEM LOGS AND FOUND ERRORS 23068 AND 23069 HAD OCCURRED. PERFORMED TROUBLESHOOTING AND FOUND THAT ERRORS 23068 AND 23069 POINTED TO THE ORIENTING PLATFORM (OP) MOTOR AND ACPD BOARD. REPLACED BOTH OP MOTOR AND ACPD BOARD TO ADDRESS REPORTED ISSUE. PERFORMED VISUAL INSPECTION AND FOUND NO PROBLEM RELATED TO REPORTED ISSUE. CHECKED SYSTEM LOGS AND CONFIRMED ERRORS 23068 AND 23069 OCCURRED. INSTALLED OP MOTOR ON AN INTERNAL EQUIPMENT, FIXTURE OR TOOL (EFT) SYSTEM AND RAN CALIBRATION SUCCESSFULLY. UNABLE TO REPLICATE REPORTED ISSUE DURING SYSTEM TESTING. THE AXIS MOTOR WAS ANALYZED AND THE COMPLAINT WAS CONFIRMED BY FA. UPON VISUAL INSPECTION, FOUND THE J19 CONNECTOR OF ACPD WAS BROKEN AND DAMAGED PADS. UNABLE TO TEST DUE TO J19 CONNECTOR WAS BROKEN AND DAMAGED PADS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER WAS HAVING BOOM ISSUES AND COULD NOT GET THE FAULTS TO CLEAR. TECHNICAL SUPPORT ENGINEER (TSE) HAD CUSTOMER HARD CYCLE THE PATIENT SIDE CART (PSC) TWICE BUT ISSUE REMAINED. DESPITE BEING ABLE TO DISABLE THE BOOM, CUSTOMER DID NOT WISH TO MOVE FORWARD WITH PSC. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275260 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1