BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22179340 · Received June 10, 2025

    Report

    Report Number
    2955842-2025-24078
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 13, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. ADVANCED TECHNICAL REVIEW (RESULTS): AN ADVANCED STAPLER LOG INVESTIGATION BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE) REVEALED THE FOLLOWING: LOGS SHOW THE SUREFORM 45 STAPLER INSTRUMENT (PART NUMBER 480445-06), WAS USED FIRST, AND IT WAS INSTALLED ON THE SYSTEM 9 TIMES AND FIRED 7 GREEN RELOADS. ON INSTALLS 1-3, 5 AND 6, ALL CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 4, THE FIRST 3 CLAMP ATTEMPTS WERE INCOMPLETE. THE 4TH CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 7, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALLS 8 AND 9, THE USER MADE 11 INCOMPLETE CLAMP ATTEMPTS. NO FIRING WAS ATTEMPTED ON EITHER INSTALL. ALL UNCLAMPS WERE SUCCESSFUL. AFTER THE 9TH INSTALL, THE INSTRUMENT WAS REMOVED AND NOT USED AGAIN IN THE PROCEDURE. NEXT, THE SECOND SUREFORM 45 STAPLER INSTRUMENT LOGS SHOW (PART NUMBER 480445-06), WAS INSTALLED ON THE SYSTEM 6 TIMES AND FIRED 6 BLACK RELOADS. ON INSTALL 1, 5, AND 6 THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 2, THE FIRST 3 CLAMP ATTEMPTS WERE INCOMPLETE. THE 4TH CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 3, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR, AND THE USER MANUALLY SELECTED THE BLACK RELOAD VIA THE USER INTERFACE ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD. THE FIRST CLAMP WAS SUCCESSFUL, FOLLOWED BY 2 INCOMPLETE CLAMPS. THE 4TH CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 4, THE FIST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. AFTER THE 6TH INSTALL, THE INSTRUMENT WAS REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS. SEE MANUFACTURER REPORT NUMBER 2955842-2025-24475 FOR DOCUMENTATION OF THE INCOMPLETE STAPLE LINE WITH A GREEN RELOAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT PRODUCED MULTIPLE INCOMPLETE STAPLE LINES. THE STAPLER WOULD NOT COMPRESS AND WOULD ONLY FIRE MILLIMETERS AT A TIME. WHEN THE FIRING SEQUENCE WAS COMPLETED, THE STAPLE LINE WAS INCOMPLETE, MALFORMED STAPLES WERE PRODUCED, AND BLEEDING WAS PRODUCED, REQUIRING INTERVENTION. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152888 SUREFORM SUREFORM 45 RELOAD BLACK GDW INTUITIVE SURGICAL, INC 48345T N/A

    Patients

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