BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16818139 · Received April 26, 2023

    Report

    Report Number
    2955842-2023-12205
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 31, 2023
    Report Date
    March 31, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO THE NUMEROUS MESSAGES RELATED TO THE TABLE MOTION. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE FOUND NO ERROR LOGS ASSOCIATED TO THE TABLE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT REGARDING TABLE MOTION ISSUE WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE IS NOT DETERMINABLE. NO REPORTED PROBLEM WAS DETECTED. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS NOTED THAT THE CUSTOMER WAS RECEIVING NUMEROUS INTERMITTENT MESSAGES RELATED TO THE TABLE MOTION. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE BUT WAS NOT ABLE TO REPRODUCE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY WERE FACING AN ISSUE WITH THE TABLE MOTION. THE TOUCHSCREEN WAS SHOWING AN INTERMITTENT MESSAGE INDICATING "READY FOR TABLE MOTION" AND "MONITOR PATIENT CLEARANCE AND PORT SITES¿ MESSAGE WITHOUT PRESSING ¿DV¿ BUTTON ON REMOTE CONTROLLER OF TS7000DV. THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY. THE TWO VIDEOS SENT BY THE CUSTOMER SHOW A CONTINUOUS INTERMITTENT MESSAGE TOGGLING FROM "READY FOR TABLE MOTION" AND "MONITOR PATIENT CLEARANCE AND PORT SITES¿. THE RESOLUTION FOR THIS ISSUE COULD MOST LIKELY BE A TABLE POWER CYCLE, BUT NO TROUBLESHOOTING WAS POSSIBLE AS THEY ARE PROCEEDING WITH THE CASE IN OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALLY WAS CHECKED BEFORE POWERING ON WITH NO ERRORS. THERE WAS NO INJURY TO THE PATIENT OR CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163653 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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