BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21630257 · Received March 18, 2025

    Report

    Report Number
    2955842-2025-08573
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    February 12, 2025
    Report Date
    February 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. THE EVENT INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AFTER THE SURGEON REVIEWED INTRAOPERATIVE FOOTAGE (THAT WAS NOT SENT TO INTUITIVE SURGICAL, INC. (ISI)), THE CONCLUSION FROM THE SURGEON IS THAT THE STAPLE LINE WAS COMPLETELY FORMED AND WAS NOT PULLED OPEN, NOR HAD IT FALLEN APART. HOWEVER, DURING INSUFFLATION THERE WAS A RUPTURE OF THE PLEURA JUST NEXT TO THE FORMED STAPLE LINE. THE CAUSE IS DIFFICULT TO DETERMINE. AN ADVANCED STAPLER LOG INVESTIGATION FOUND THE STAPLER WAS INSTALLED ON THE SYSTEM 9 TIMES AND FIRED 9 RELOADS (3 BLUE, 1 BLACK, 1 WHITE, 2 BLACK, 1 BLUE, 1 WHITE, IN THAT ORDER). THERE WERE NO INCOMPLETE CLAMPS OR UNCLAMPS BY THIS INSTRUMENT. ON EACH INSTALL, ALL CLAMP ATTEMPTS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. AFTER THE 9TH FIRING, THE INSTRUMENT WAS REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE SYSTEM. ADDITIONALLY, A REVIEW OF THE SITE'S SYSTEM LOGS FOUND THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PULMONARY LOBECTOMY, THE SUREFORM 45 INSTRUMENT FIRED A BLUE RELOAD ON THE PARENCHYMA WITH NO ISSUES. HOWEVER, WHEN MANIPULATING THE TISSUE AT THE END OF THE PROCEDURE, THE ENTIRETY OF THIS PARTICULAR RELOAD'S STAPLE LINE TORE APART. THERE WERE NO OTHER ISSUES WITH THE OTHER STAPLE LINES PRODUCED IN THE PROCEDURE. THE PATIENT HAS NO RELEVANT COMORBIDITIES AND HAS NOT HAD RADIATION THERAPY. THE PREOP DIAGNOSIS WAS NON-SMALL CELL LUNG CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884466 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

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