BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16489989 · Received March 6, 2023

    Report

    Report Number
    2955842-2023-11081
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 DUE TO NOT WANTING TO DELAY THE PROCEDURE FOR TROUBLESHOOTING. AFTER THE CASE WAS COMPLETED, THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE OF NO IMAGE IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE BY FOLLOWING THE TROUBLESHOOTING STEPS PROVIDED BY INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. THE SYSTEM IS IN WORKING WITH NO ISSUES. NO SITE VISIT WAS REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS NO IMAGE IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC). THE SURGEON DID NOT WANT TO DELAY THE PROCEDURE FOR TROUBLESHOOTING AND ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS NO RIGHT EYE IMAGE IN THE SURGEON SIDE CONSOLE (SSC). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE LIVE LOGS AND FOUND A SINGLE 45308 ERROR AND BLUE FIBER RELATED ERRORS. THE TSE RECOMMENDED TURNING THE SYSTEM OFF AND VERIFYING THE BLUE FIBER CONNECTION BETWEEN THE SSC AND VISION SIDE CART (VSC), BUT THE SURGEON DID NOT WANT TO PERFORM A POWER CYCLE. AFTER THE SURGEON HAD CONVERTED THE CASE TO OPEN SURGERY, THE CUSTOMER HARD POWER CYCLED THE SSC AND RESEATED THE BLUE FIBER CABLE AT THE SSC AND VSC. THE SYSTEM POWERED BACK ON WITH NO ISSUES. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. ON (B)(6)2023, ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITHOUT ANY INJURY OR HARM TO THE PATIENT. THE SURGEON CONVERTED TO OPEN SURGERY BECAUSE OF THE RIGHT EYE VISION LOSS. THE SURGEON DID NOT WANT TO DELAY THE PROCEDURE FOR TROUBLESHOOTING AND INSTEAD CHOSE TO CONVERT TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631039 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-23 N/A 00886874110744

    Patients

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