BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17208604 · Received June 27, 2023

    Report

    Report Number
    2955842-2023-16641
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 2, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DIFFICULTY WITH ADVANCING THE STAPLER INSTRUMENT THROUGH THE CANNULA WITH 23/40 FIBER ERRORS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND CONFIRMED THE STAPLER ISSUE WAS LIKELY DUE TO SLEEVE ON THE INSTRUMENT IMPACTING THE MOVEMENT THROUGH THE CANNULA. THE SITE CONVERTED TO OPEN SURGERY BEFORE TRYING A NEW CANNULA AND NEW SHEATH. THE FSE ALSO SPOKE WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REGARDING ERROR CODE 23 AND BLUE FIBER CABLES. IT IS KNOWN THAT THESE PARTICULAR CABLES ARE ~5 YEARS OLD NOW AND LIKELY WORN OUT. THE FSE WAS TO PROVIDE A REPLACEMENT CABLE. NO ON-SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE ENDOWRIST 30 STAPLER WOULD NOT ADVANCE THROUGH THE CANNULA. THE CALLER STATED THEY TRIED CHANGING THE CANNULA FROM UNIVERSAL TO 12MM. THE CALLER FURTHER STATED THAT THEY ALSO CHANGED THE SHEATH ON THE STAPLER, BUT THE SURGEON ENDED UP CONVERTING TO OPEN BEFORE THEY COULD TRY THE STAPLER AGAIN WITH THE NEW SHEATH. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND SAW 23/40 FIBER ERRORS. CALLER CONFIRMED THEY HAD TO REBOOT TWICE BECAUSE OF FIBER ERRORS. THE CALLER STATED THEY CONVERTED TO OPEN "BECAUSE IT WAS A HARD CASE". THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647089 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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