BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 24537812 · Received March 6, 2026

    Report

    Report Number
    2955842-2026-15255
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 2, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114735
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED AND FOUND IN THE SYSTEM LOGS, NO HISTORY WAS FOUND TO INDICATE THE FAILURE OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, BOTH VIDEO INPUT LEAF (VIL) AND SURGEON CONSOLE LEAF (SCL) BOARDS WERE FOUND DAMAGED DUE TO WEAR AND TEAR. THE PMSC WAS INSTALLED ON THE GOLDEN SYSTEM TO RUN VIDEO AND AUDIO TESTS, 10 POWER CYCLES, AND SITTING IDLE FOR ONE HOUR. ALL VIL AND VIDEO OUTPUT LEAF (VOL) PORTS WERE TESTED AND HAD GOOD IMAGE. ALSO, AUDIO WAS TESTED WITH CLEAR SOUND. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED, BUT NO ERROR COULD BE IDENTIFIED. THE COMPLAINT REGARDING A GREEN SCREEN ONLY IN SURGEON SIDE CART (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL ISSUES RESULTED FROM THE SCL BOARDS LOCATED ON PMSC.

    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. FSE REPLACED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    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 TRAINING/DEMO OF THE DA VINCI SYSTEM, THE USER ENCOUNTERED A GREEN SCREEN ISSUE DISPLAYED ONLY ON THE SURGEON SIDE CONSOLE'S HIGH RESOLUTION STEREO VIEWER (HRSV-L), WHILE THE VISION SIDE CART HAD NO ISSUES. THE USER CONDUCTED BOTH A POWER CYCLE AND A HARD POWER CYCLE OF THE SYSTEM, BUT THE ISSUE PERSISTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE ENTIRE SCREEN ON THE LEFT EYE WAS SOLID GREEN WITH NO VISIBLE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366732 DA VINCI SP SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380940-31 N/A 00886874114735

    Patients

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