BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22162651 · Received June 7, 2025

    Report

    Report Number
    2955842-2025-24273
    Event Type
    Malfunction
    Date Received
    June 7, 2025
    Date of Event
    May 20, 2025
    Report Date
    May 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE AFFECTED FIBER OPTIC CABLE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF ERROR 55 MAY BE ATTRIBUTED TO USER-INDUCED PROBLEMS INCLUDING LOOSELY CONNECTED, DIRTY, DAMAGED, IMPROPERLY SEATED, OR DISCONNECTED BLUE FIBER CABLE. THE SYSTEM IS PLACED IN A RECOVERABLE SOFT-LOCK MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, AN INTUITIVE SURGICAL (IS) TECHNICAL SERVICE ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE BY THE CLINICAL SALES REPRESENTATIVE (CSR) TO REPORT ON CUSTOMER BEHALF, THAT THEY WERE HAVING AN ISSUE POWERING THE SYSTEM ON. CSR STATED THEY WERE HAVING A BLUE SCREEN, AND IT WAS NOT POWERING ON. TSE REVIEWED ERROR LOGS AND FOUND ERRORS 55, 54 POINTING TO PATIENT SIDE CART (PSC) WHEN CONNECTED TO UPPER PORT ON CORE. TSE CONFIRMED ON EVENT LOGS, THAT USER RESOLVED THE ISSUE BY CONNECTING THE PSC WITH THE BLUE FIBER CABLE (BFC) OF SECONDARY SURGEON SIDE CART (SSC), BEGINNING THE PROCEDURE WITH ONE SSC. TSE REVIEWED ON SYSTEM EVENTS THAT, AFTER PROCEDURE, USER CONNECTED THE WHOLE SYSTEM AND ERROR 54 WAS BACK ON CORE UPPER PORT POINTING TO PSC CONNECTION. TSE CALLED OR SUPERVISOR AND GUIDED TO SWAP THE BFC BETWEEN THE TWO UPPER PORTS AND ISSUE REMAINED ON PORT 0, THEREFORE, AN ISSUE WITH THE BFC WAS DISCARDED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. THERE WAS A DELAY OF LESS THAN 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: IT WAS STATED THAT CLINICAL SPECIALIST WAS UNABLE TO RECALL IF THE INITIAL CONFIGURATION OF THE PROCEDURE WAS SET UP FOR DUAL SURGEON SIDE CONSOLES (SSCS) USE AND WAS UNABLE TO CONFIRM IF THE SECONDARY SSC WAS ABANDONED AND PROCEDURE CONTINUED WITH ONLY ONE SSC.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492766 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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