BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24514149 · Received March 4, 2026

    Report

    Report Number
    2955842-2026-15066
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 10, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    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. FSE IDENTIFIED THAT PROBLEM WAS WITH THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) BOARD IN SURGEON SID CONSOLE (SSC1) AND REPLACED THE PMSC. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS NOT RECEIVED THE PMSC FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WAS ANALYZED. ERROR 607 WAS FOUND IN ARTEMIS CONFIRMING THE REPORTED PROBLEM FROM THE FIELD. A VISUAL INSPECTION FOUND BOTH VIDEO INPUT LEAF (VIL) BOARDS AND SURGEON CONSOLE LEAF (SCL) BOARDS DAMAGED DUE TO WEAR AND TEAR. THE PMSC WAS INSTALLED ONTO AN IN-HOUSE SYSTEM WHERE BOTH THE VIL BOARDS AND SCL BOARDS WERE NOT PRESENT ON LAPTOP APP. ALSO, UPON POWERING UP, ERROR 48100 OCCURRED INDICATING THAT THERE WAS AN AUDIO ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE VIL BOARDS AND SCL BOARDS. THIS ISSUE CAN BE RESOLVED BY HAVING THE FSE REPLACE THE PSMC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY W/ OTHER URINARY DIVERSION SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A REPEATED RECOVERABLE FAULT 607 OCCURRED. THE TSE REVIEWED THE LOGS AND INSTRUCTED THE USER TO DISCONNECT SURGEON SIDE CONSOLE (SSC)1) AND RELEASE THE TISSUE GRASPED BY THE FORCE BIPOLAR FORCEPS INSTRUMENT. AFTER FOLLOWING THESE STEPS, THE SYSTEM BOOTED UP FINE, AND THE CUSTOMER WAS ABLE TO PROCEED WITH THE SURGERY USING THE OTHER SSC. A PROCEDURE DELAY WAS REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149896 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-28 N/A 00886874110744

    Patients

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