BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 23701742 · Received December 3, 2025

    Report

    Report Number
    2955842-2025-47198
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 17, 2025
    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
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE BLUE FIBER CABLE AND THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR ON SURGEON SIDE CONSOLE (SSC) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HRSV MONITOR ; HOWEVER, FAILURE ANALYSIS INVESTIGATIONS ARE UNDER PROGRESS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE COMPONENT WAS ANALYZED AND IT WAS FOUND TO HAVE AN ERROR 119 ON SYSTEM LOGS. THE UNIT WAS THEN INSTALLED ONTO THE GOLDEN SYSTEM WHERE IT FUNCTIONED AS EXPECTED. THE SYSTEM RAN 10 POWER CYCLES BUT THE REPORTED ISSUE COULD NOT BE REPLICATED. THE HRSV MONITOR HAD A CLEAR IMAGE DISPLAY. NO BLACKOUTS WERE OBSERVED DURING TESTING. THIS UNIT WAS FULLY FUNCTIONAL. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED, THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN ELECTRICAL COMPONENT ISSUE IN THE HRSV. WHILE FAILURE ANALYSIS CONFIRMED THE ISSUE VIA LOG REVIEW, IN-HOUSE TESTING WAS UNABLE TO REPLICATE THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE LEFT MONITOR ON HIGH RESOLUTION STEREO VIEWER (HRSV) HAD NO IMAGE OR ARM POD INFO AT SURGEON SIDE CONSOLE (SSC). AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED CUSTOMER TO DO A POWER CYCLE. CUSTOMER STATED THAT THEY WILL TRY TO DO IT LATER IN THE PROCEDURE BUT, FOR NOW THEY WERE PROCEEDING AS IT IS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857360 DA VINCI SP SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380940-40 N/A 00886874114735

    Patients

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