BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 21071654 · Received January 3, 2025

    Report

    Report Number
    2955842-2025-00039
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 12, 2024
    Report Date
    December 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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 WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND THE FSE REPLACED THE VISION SIDE CART (VSC) COMMON COMPUTER CONTROLLER (CCC) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    THE COMMON COMPUTER CONTROLLER (CCC) WAS RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE CCC WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE CCC WAS INSTALLED ON THE KNOWN GOOD IN-HOUSE SYSTEM AND THE VISION SIDE CART (VSC) MONITOR COULD NOT SHOW FULL DISPLAY ON THE SCREEN. SYSTEM COULD NOT FULLY POWER ON AND HAD "INSUFFLATOR DISABLED" MESSAGE ON THE VSC TOUCH SCREEN. THE CCC WAS TAKEN TO A PROGRAMMING STATION WHERE IT WAS CONFIRMED TO BE BRICKED. THE ROOT CAUSE WAS ATTRIBUTED TO A BRICKED CCC.

    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) FROM OFFSITE TO REPORT THAT THE SYSTEM HAD POWER ISSUE DUE TO ROOM POWER. THE SYSTEM LIVE LOGS AREN'T AVAILABLE. THE CSR STATED THE CUSTOMER CAN¿T GET THE SYSTEM TO POWER UP NORMAL. THE CSR LATER CONTACTED THE TSE AND REPORTED THE STAFF HAD TRIED TO POWER EACH COMPONENT UP IN STAND-ALONE MODE AND THE VISION SIDE CART (VSC) AND THE SURGEON SIDE CONSOLE (SSC) WOULD ONLY SHOW A FLASHING BLUE POWER BUTTON. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER CONFIRMED THE PROCEDURE WAS CONVERTED DUE TO SYSTEM ISSUE. THE CUSTOMER INFORMED ADDITIONAL PORTS WERE NOT PLACED. THERE WAS NO INJURY/HARM TO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600366 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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