BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24682846 · Received March 24, 2026

    Report

    Report Number
    2955842-2026-17689
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    October 27, 2025
    Report Date
    March 24, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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. THE FSE REPLACED LEFT MASTER TOOL MANIPULATOR (MTML) ON SURGEON SIDE CONSOLE (SSC)1 AS THERE WAS A REPEATED RECOVERABLE ERROR 23062. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MTML WAS ANALYZED AND FAILURE ANALYSIS CONFIRMED BUT COULD NOT REPLICATE THE REPORTED ISSUE. A REVIEW OF THE LOGS CONFIRMED UNIT EXPERIENCED 23062 ERROR CODE ON MULTIPLE POWER CYCLES. THE UNIT WAS VISUALLY INSPECTED AND FOUND NO EXTERNAL DAMAGES. THE UNIT WAS PLACED ON IN-HOUSE SYSTEM AND WAS DRIVEN WITH NO ISSUES. UPON FURTHER TESTING, THE UNIT WAS PLACED ON TESTING PLATFORM FOR FURTHER TESTS. UNIT KEPT FAILING ON MULTIPLE TESTS. SLOW FRICTION TESTS PASSED. SINE CYCLE FAILED WITH ERRORS 23152 AND 32098. AFTER RE-EXECUTING RE-CALIBRATION TESTS, UNIT PASSED. HOWEVER, ERROR WAS OBSERVED ON GRIP TORQUE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS. PROBABLE ROOT CAUSE IS ATTRIBUTED TO A BAD GRIP SPRING, ROLL MOTOR, AND SLIPRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED REPEATED RECOVERABLE ERROR (B)(4) WHILE SERVICING ANOTHER DV5 INSTALLATION. THE ERROR POINTS TO A FAULT ON THE LEFT-HAND CONTROL OF CONSOLE 1. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER CONTACTED ISI TECHNICAL SUPPORT ENGINEER, AND AFTER REVIEW, THEY RECOMMENDED REPLACING THE MASTER TOOL MANIPULATOR (MTM) AS THE ERROR APPEARED TO BE PROGRESSIVELY WORSENING. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44838 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-46 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1