BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22414225 · Received July 7, 2025

    Report

    Report Number
    2955842-2025-26270
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    May 19, 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 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 (2 BLUE, FOLLOWED BY 5 WHITE). ON INSTALL 1, THE FIRST CLAMP WAS INCOMPLETE. THE NEXT CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 2-3 PAUSES FOR COMPRESSION. ON INSTALLS 2, 5, AND 7, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 3, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 2 PAUSES FOR COMPRESSION. ON INSTALL 4, THE FIRST CLAMP WAS ABORTED BY THE USER. THE NEXT CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 6, THE FIRST CLAMP WAS INCOMPLETE. THE NEXT CLAMP WAS SUCCESSFUL AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. AFTER THE 7TH INSTALL, THE INSTRUMENT WAS 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 AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY AND PARAESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE, THE STAPLE LINE LEAKED WHERE A SUREFORM 60 RELOAD WAS FIRED. INTRAOPERATIVELY, THE SUREFORM 60 STAPLER INSTRUMENT WORKED AS INTENDED; THERE WERE NO REPORTED ERROR MESSAGES, PAUSES FOR COMPRESSIONS, OR DIFFICULTIES DURING THE FIRING SEQUENCES. ALL STAPLE LINES WERE COMPLETE. A NEGATIVE INDOCYANINE GREEN (ICG) LEAK TEST WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. IT WAS SUSPECTED A LEAK OCCURRED AT THE GASTROESOPHAGEAL JUNCTION (GEJ), OR THE ESOPHAGUS. THE PATIENT REQUIRED REOPERATION AND STENTS WERE PLACED. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152869 SUREFORM STAPLER 60 RELOAD GDW INTUITIVE SURGICAL, INC 48360 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.