BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 21367832 · Received February 12, 2025

    Report

    Report Number
    2955842-2025-01384
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 17, 2025
    Report Date
    January 17, 2025
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMMON COMPUTER CONTROLLER (CCC) WAS EVALUATED BY THE FAILURE ANALYSIS TEAM. THE CCC WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD EQUIPMENT, FIXTURE, OR TOOL (EFT) AND POWERED ON WITH NO ISSUES. THE SURGEON SIDE CONSOLE (SSC) WAS CHANGED TO CONSOLE TWO, WHERE STILL NO ISSUES WERE FOUND. AN IDLE TEST WAS PERFORMED FOR APPROXIMATELY 40 HOURS, AND THE SYSTEM WAS POWER CYCLED FIVE TIMES WITH NO ISSUES.

    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 INSPECTED BLUE FIBER CABLES AND NO DAMAGE WAS FOUND. NO DAMAGE ON FIBER PORTS WAS SEEN DURING INSPECTION. BLUE FIBER CABLES WERE SWAPPED BETWEEN CONSOLES, AND ISSUE DID NOT REOCCUR AND DID NOT TRANSFER BETWEEN CONSOLES. SYSTEM DID NOT BOOT UP WITH ANY ISSUES AFTER RESEATING BLUE FIBERS. THE FSE REPLACED COMMON COMPUTER CONTROLLER (CCC) DUE TO MULTIPLE CALLS AND ISSUES ON SECOND SURGEON SIDE CONSOLE BY CUSTOMER. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE CCC, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED.

    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 DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THEY ARE STILL HAVING PROBLEMS WITH CONSOLE 2. THE CUSTOMER INFORMED THAT CONSOLE 2 IS NOT CONNECTING/COMMUNICATING WITH THE TOWER. PRIOR TO CALLING, THE CUSTOMER TRIED RESEATING THE FIBER CABLE FROM THE TOWER TO CONSOLE 2 AND POWER CYCLING THE SYSTEM WITH NO CHANGE. CUSTOMER ELECTED TO DISCONNECT CONSOLE 2 TO CONTINUE WITH THE PROCEDURE. THE CSR INFORMED THAT THE LED NEXT TO THE FIBER CONNECTION ON THE TOWER (THAT RUNS TO CONSOLE 2) WAS NOT ILLUMINATED AT ALL. NO ADDITIONAL TROUBLESHOOTING WAS PERFORMED DUE TO THE ONGOING CASE. TSE RECOMMENDED SWAPPING THE FIBER CONNECTION BETWEEN CONSOLE 1 AND CONSOLE 2 TO CHECK IF THE ISSUE FOLLOWS THE FIBER CABLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER SAID THE ISSUE OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965575 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

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