BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22420299 · Received July 7, 2025

    Report

    Report Number
    2955842-2025-26273
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 11, 2025
    Report Date
    June 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON BELIEVED THE STAPLE LINE LEAK ISSUE COULD HAVE BEEN CAUSED BY AN ISSUE WITH UNIVERSAL SURGICAL MANIPULATOR (USM) # 1 INSTALLED ON THE PATIENT SIDE CART (PSC). AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REMOVED AND REPLACED USM #1. IN ADDITION, THE FSE CALIBRATED THE LEFT MASTER TOOL MANIPULATOR (MTM) ON THE SURGEON SIDE CONSOLE (SSC) AT THE SITE. THE FSE TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ISI HAS NOT RECEIVED THE USM OR WHITE SUREFORM 60 RELOADS FOR FAILURE ANALYSIS EVALUATION. A STAPLER LOG REVIEW REVEALED THE FOLLOWING: A SUREFORM 60 STAPLER INSTRUMENT WAS INSTALLED ON THE SYSTEM 7 TIMES AND FIRED 7 SUREFORM 60 RELOADS (1 BLUE, FOLLOWED BY 6 WHITE). ON INSTALLS 1-6, THE FIRST CLAMP WAS SUCCESSFUL. ON INSTALL 1, THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 2, THE FIRING WAS COMPLETED WITH 5 PAUSES FOR COMPRESSION. ON INSTALLS 3 AND 4, THE FIRINGS WERE COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 5, THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 6, THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 7, THE FIRST CLAMP WAS INCOMPLETE. THE NEXT CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 3-4 PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, TWO STAPLE LINES LEAKED WHERE WHITE SUREFORM 60 RELOADS WERE FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT, REQUIRING INTERVENTION. THE SUREFORM 60 STAPLER INSTRUMENT WORKED AS INTENDED THROUGHOUT THE PROCEDURE; THERE WERE NO REPORTS OF ANY ERROR MESSAGES, PAUSES FOR COMPRESSIONS, OR DIFFICULTIES DURING THE FIRING SEQUENCES. THE SURGEON INDICATED THAT THE FIRST TWO FIRES WITH THE SUREFORM 60 STAPLER INSTRUMENT WERE WITH BLUE SUREFORM 60 RELOADS AND THE STAPLE LINES FROM THOSE STAPLER RELOADS WERE INTACT. NO INTERVENTION WAS REQUIRED. AN INDOCYANINE GREEN (ICG) LEAK TEST WAS PERFORMED, WHICH WAS POSITIVE, SHOWING A LEAK AT TWO STAPLE LINES. THE STAPLE LINES AND THE OMENTOPLASTY WERE OVER-SUTURED TO REPAIR THE LEAKS. A SECOND LEAK TEST WAS PERFORMED AND WAS NEGATIVE. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE PATIENT IS RECOVERING WELL WITH NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W-06 N/A

    Patients

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