BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18611359 · Received January 30, 2024

    Report

    Report Number
    2955842-2024-10830
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    January 12, 2024
    Report Date
    January 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    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 EVENT. FSE REPLACED THE ERBE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE C-0 ERROR WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. ON STARTUP, THE UNIT DISPLAYED ERROR C-42.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED ERBE ACTIVATION ERRORS. THE TECHNICAL SERVICE ENGINEER (TSE) VIEWED SYSTEM LOGS AND CONFIRMED C-42 ERRORS. ALSO, TSE SUGGESTED POWER CYCLE THE SYSTEM AND GENERATOR. THE CUSTOMER STATED THAT THEY ATTEMPTED TO POWER CYCLE, BUT THE ERRORS RETURNED. THERE WAS NO REPORT OF ANY INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALLY WAS CHECKED, AND NO ERROR CODES POPULATED AFTER WARMING UP AND IT DID POWER ON WITHOUT ERRORS. INITIALLY THE CUSTOMER UNPLUGGED AND PLUG ALL CABLES AT LEAST TWICE. THEN CALLED FOR TECHNICAL SUPPORT AFTER SECOND ATTEMPT. TECHNICAL SUPPORT SUGGESTED FOR US TO SHUT THE SYSTEM DOWN AND RESTART (ERROR CODE REMAINED). FURTHERMORE, TECHNICAL SUPPORT SUGGESTED TURNING SYSTEM OFF AND SWITCHING ALL BREAKERS OFF TO ALL EQUIPMENT AND RESTART. AFTER FOLLOWING THESE SUGGESTIONS, THE SYSTEM STILL GAVE ERROR CODE AND TECHNICIAN DEEMED THAT THE EQUIPMENT ERROR CODE WOULD NOT ALLOW TO PROCEED WITH THE PROCEDURE ON THIS ROBOT. ALSO, GENERATOR UNIT WAS REPLACED BUT DUE TO THE TIME FOR SERVICE TECH TO REPLACE THE GENERATOR THE SURGEON DECIDED TO CANCEL THE PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA. PHYSICIAN OPTED NOT TO DO TRADITIONAL LAPAROSCOPIC SURGERY AND DECIDED TO CANCEL THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246604 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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