BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067416 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-15757
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    December 16, 2021
    Report Date
    December 16, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 COMPLAINT. THE FSE POWERED ON THE VISION SIDE CART (VSC), BUT IT WOULD NOT POWER ON TO GET INTO STANDBY MODE. THE FSE FOUND DRIED LIQUID INSIDE THE FRONT BEZEL, ON THE VIDEO SLICER #1 AND #2 BOARDS, AND ON ISI CORE CONTROLLER (ICC) BOARD. THE FSE REPLACED THE ISI CORE ASSEMBLY TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ISI CORE ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE ISI CORE UNIT WAS TESTED ON THE TEST SYSTEM. UPON TURNING ON THE REAR CIRCUIT BREAKER, THE FAN SPIN, ALL LIGHT EMITTING DIODES (LEDS) ON THE PERSONALITY MODULE VIDEO AUDIO (PMAV) LIT UP, BUT THE FRONT POWER SWITCH WOULD NOT GO TO STANDBY. AFTER TROUBLESHOOTING, THE ISI CORE CONTROLLER (ICC) BOARD AND VIDEO SLICE (VSL) 1 BOARD HAVE FAILED. THERE WAS SIGN OF FLUID RUNNING DOWN THE CORE. THE UNIT WAS SCRAPPED DUE TO FLUID CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNKNOWN THORACIC SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A RECOVERABLE ERROR WITH NOT CONNECTED TO THE VISION SIDE CART (VSC) MESSAGE ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD. SOMEONE IN THE OPERATING ROOM STEPPED ON SOME CABLES AND THE SCREEN HAD RAINBOW COLORS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED POWER CYCLING THE SYSTEM AND RESEATING ALL BLUE FIBER CABLES. THE SURGEON ELECTED TO CONVERT TO A LAPAROSCOPIC SURGERY WITHOUT PERFORMING ANY TROUBLESHOOTING STEPS. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND CONFIRMED THAT THE LAPAROSCOPIC PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188500 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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