BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUREFORM

    MDR report key: 23117114 · Received September 22, 2025

    Report

    Report Number
    2955842-2025-37952
    Event Type
    Death
    Date Received
    September 22, 2025
    Date of Event
    August 28, 2025
    Report Date
    August 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: ENDOSCOPE 0 DEGREE, CADIERE FORCEPS INSTRUMENT, TIP-UP FENESTRATED GRASPER INSTRUMENT, CURVED BIPOLAR DISSECTOR INSTRUMENT, LARGE CLIP APPLIER INSTRUMENT, AND SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT. A REVIEW OF THE SYSTEM LOGS FOUND NO ERRORS WERE LOGGED DURING THE PROCEDURE. ADDITIONALLY, A LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM ALSO FOUND NO ERRORS OCCURRED. A REVIEW OF THE STAPLER LOGS SHOWS THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WAS INSTALLED ON THE SYSTEM 1 TIME AND FIRED 1 WHITE SUREFORM 45 RELOAD. ON THE ONLY INSTALL, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR, AND THE USER MANUALLY SELECTED THE WHITE RELOAD VIA THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD. THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE E-STOP WAS PRESSED 2 TIMES APPROXIMATELY 1 HOUR AFTER THE COMPLETED UNCLAMP. IT IS UNCLEAR WHY THE E-STOP WAS USED AS THE FIRING AND SUBSEQUENT UNCLAMP WERE SHOWN AS SUCCESSFUL IN THE LOGS. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THERE WERE NO ADDITIONAL ERRORS IN THE LOGS PERTAINING TO THE USE OF THIS STAPLER. AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) REVIEW OF THE EVENT WAS PERFORMED AND CONCLUDED THAT THE PATIENT IN THIS REPORT DIED AFTER AN ATTEMPTED PULMONARY LOBECTOMY PROCEDURE IN WHICH THE PULMONARY ARTERY BLED FROM A TEAR POSTERIORLY WHEN THE STAPLER WAS RELEASED. THE STAPLING SEQUENCE WAS AS EXPECTED UP UNTIL THE TIME THE STAPLER WAS RELEASED AND THE VESSEL BLED. HOW THE POSTERIOR TEAR OCCURRED IS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF THE STAPLER OR ANY OTHER INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PULMONARY ARTERY (PA) TORE AND BLED AFTER A WHITE SUREFORM 45 RELOAD WAS FIRED WITH A SUREFORM 45 STAPLER INSTRUMENT. THE PATIENT ULTIMATELY EXPIRED. WHILE STAPLING ACROSS THE PA WITH A WHITE SUREFORM 45 RELOAD, THE FIRING SEQUENCE WAS COMPLETED WITHOUT ANY ERROR MESSAGES OR COMPLICATIONS. WHEN THE STAPLER INSTRUMENT WAS OPENED, BLEEDING WAS OBSERVED, AND IT WAS NOTED THAT THE PA WAS TORN POSTERIORLY. THE SURGEON USED A CADIERE FORCEPS INSTRUMENT TO GRASP THE PA TO LIMIT THE BLEEDING. THE EMERGENCY STOP BUTTON (E-STOP) WAS PRESSED, AND ALL OTHER INSTRUMENTS WERE REMOVED FROM THE SYSTEM. THE PROCEDURE WAS EMERGENTLY CONVERTED TO AN OPEN THORACOTOMY. ONCE ACCESS WAS GAINED THROUGH THE CHEST, THE INSTRUMENT RELEASE KEY (IRK) WAS USED TO SUCCESSFULLY RELEASE THE CADIERE FORCEPS INSTRUMENT FROM THE PA. THE BLEEDING WAS THEN ATTEMPTED TO BE CONTROLLED AS AN OPEN APPROACH. ULTIMATELY, THE PATIENT EXPIRED DUE TO THE HEMORRHAGE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942005 SUREFORM SUREFORM 45 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48345W N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death| R DA VINCI INSTRUMENTS AND ACCESSORIES