BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18096907 · Received November 8, 2023

    Report

    Report Number
    2955842-2023-19857
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 12, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY BECAUSE THE SYSTEM FAULTED. HOWEVER, THROUGH TROUBLESHOOTING, THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) IDENTIFIED THAT THE VISION SIDE CART CIRCUIT BREAKER WAS IN THE OFF POSITION. ONCE THE CIRCUIT BREAKER WAS MOVED TO THE ON POSITION, THE SYSTEM POWERED ON NORMALLY, AND THE ISSUE WAS RESOLVED OVER THE PHONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAFF CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT MID-PROCEDURE THE SYSTEM ERRORED OUT. THE CALLER STATED THERE WAS A MESSAGE ON THE SURGEON SIDE CONSOLE (SSC) SAYING IT WAS NOT CONNECTED TO THE VISION TOWER AND TO CHECK THE BLUE FIBER CONNECTIONS. THE TSE WALKED THE CALLER THROUGH A HARD POWER CYCLE ON THE VISION CART AND FOUND THAT THE CIRCUIT BREAKER WAS IN THE OFF POSITION ON THE VISION SIDE CART (VSC). THE CALLER TURNED THE CIRCUIT BREAKER TO THE ON POSITION AND SYSTEM POWERED ON NORMALLY WITH NO FURTHER ISSUES. THE CALLER STATED THE SURGEON CONVERTED THE PROCEDURE TO OPEN DUE TO THIS ISSUE PRIOR TO THE CALL. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO OPEN DUE TO THE REPORTED ISSUE. THE SURGEON COULD NOT FIGURE OUT WHY THE SYSTEM ERRORED OUT INITIALLY AND, HENCE, DECIDED TO GO FOR OPEN SURGERY BEFORE CALLING TECHNICAL SUPPORT. THERE WERE NO POST-OPERATIVE COMPLICATIONS AFTER OPEN SURGERY. THE PATIENT INFORMATION IS CONFIDENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511444 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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