BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 19765007 · Received July 17, 2024

    Report

    Report Number
    2955842-2024-16905
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 18, 2024
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SUREFORM 60 STAPLER INSTRUMENT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS EVALUATION HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. AN ADVANCED STAPLER LOG REVIEW SHOWS THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 5 TIMES AND FIRED 5 RELOADS (1 GREEN, FOLLOWED BY 4 BLUE). ON INSTALL 1, THE FIRST CLAMP WAS ABORTED BY THE USER ABOUT HALFWAY TO COMPLETION. THE NEXT 3 CLAMP ATTEMPTS WERE SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 2-3 PAUSES FOR COMPRESSION. ON INSTALLS 3 AND 5, THE FIRST CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 4, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 0-1 PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THERE WERE NO STAPLER RELATED ERRORS IN THE SYSTEM LOGS. THE CUSTOMER STATED THE ISSUE OCCURRED ON THE WHITE AND BLUE RELOADS. HOWEVER, LOGS SHOW WHITE RELOADS WERE NOT USED IN THIS PROCEDURE AND FURTHER CLARIFICATION HAS NOT BEEN RECEIVED ON HOW MANY OF THE 5 RELOADS USED IN THIS PROCEDURE (4 BLUE, 1 GREEN) BLED. MANUFACTURER REPORT 2955842-2024-16906 DOCUMENTS REPORTABILITY AGAINST THE BLUE RELOAD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE SUREFORM 60 INSTRUMENT USED IN THE PROCEDURE WAS RETURNED FOR FAILURE ANALYSIS (FA), BUT FA DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE CHANNEL SPRANG BACK OPEN WHEN IN THE UNCLAMPED STATE. WHEN TESTED IN-HOUSE, THE INSTRUMENT INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES. IT PASSED THE RECOGNITION AND ENGAGEMENT TESTS, MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY. IN TESTING, THE INSTRUMENT FIRED SUCCESSFULLY USING A GREEN 60 RELOAD AND A BLUE 60 RELOAD. THE CUT-LINES APPEARED SMOOTH AND CONSISTENT, WITH NO JAGGED EDGES OR TEARING OBSERVED. ALL STAPLES WERE DEPLOYED AND CORRECTLY FORMED INTO THE PROPER B-SHAPE. THERE WAS NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SLEEVE GASTRECTOMY, THE "CARTRIDGES" WERE NOT WORKING PROPERLY, AND THE ENTIRE STAPLE LINE IS STILL BLEEDING AFTER USE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THROUGH FOLLOW UP WITH THE SURGEON THROUGH THE ROBOTICS COORDINATOR (ROCO), IT WAS LEARNED THAT THE SURGEON HAD THE SAME ISSUE WHILE USING THE WHITE AND BLUE RELOADS AND HAD TO USE 5 ENDOCLIPS TO ACHIEVE HEMOSTASIS. PER THE SURGEON, MOST OF THE STAPLES APPEARED TO HAVE COMPLETELY FORMED, HOWEVER, SOME WERE NOTED TO BE DERANGED. BUTTRESSING MATERIAL WAS USED, AND MOST OF THE BLEEDING OCCURRED FROM THE UNBUTTRESSED PORTION OF THE STAPLE LINE OR ON THE SMALL BOWEL WHEN USING THE WHITE CARTRIDGES. THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364259 SUREFORM STAPLER 60 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48360G UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES