BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 21687142 · Received March 25, 2025

    Report

    Report Number
    2955842-2025-11252
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 28, 2025
    Report Date
    February 28, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVESTIGATION IS IN PROGRESS. AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER REVIEWED THE STAPLER LOGS FOR THE STAPLER USED IN THIS EVENT AND THE FOLLOWING INFO WAS PROVIDED: LOGS SHOW SUREFORM 45 STAPLER (PART NUMBER: 480545-04, LOT NUMBER: K10241205-0128) WAS INSTALLED FIRST, HOWEVER THE SYSTEM FAILED TO DETECT THE RELOAD COLOR, AND THE USER MANUALLY SELECTED THE WHITE RELOAD VIA THE GEMINI USER INTERFACE (GUI) ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD. NO CLAMPING OR FIRING WAS ATTEMPTED. NEXT, LOGS SHOW SUREFORM 45 STAPLER (PART NUMBER: 480445-06, LOT NUMBER: K14241024-0061) WAS INSTALLED ON THE SYSTEM 5X AND FIRED 5 GREEN RELOADS. ON EACH INSTALL, ALL CLAMPS WERE SUCCESSFUL. ON INSTALL 1, THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALLS 2-5, THE FIRINGS WERE COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. NEXT, LOGS SHOW SUREFORM 45 STAPLER (PART NUMBER: 480445-06, LOT NUMBER: U12241115-0109) WAS INSTALLED ON THE SYSTEM 3X AND FIRED 3 RELOADS (1 GREEN, FOLLOWED BY 2 BLACK). ON EACH INSTALL, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. NEXT LOGS SHOW SUREFORM 45 STAPLER (PART NUMBER: 480545-04, LOT NUMBER: K10241205-0128) WAS RE-INSTALLED A SECOND TIME, WITH A WHITE RELOAD. THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. LASTLY, LOGS SHOW SUREFORM 45 STAPLER (PART NUMBER: 480445-06, LOT NUMBER: U12241115-0109), WAS RE-INSTALLED ON THE SYSTEM 4 MORE TIMES AND FIRED 4 MORE RELOADS (1 GREEN, 1 BLACK, 2 GREEN, IN THAT ORDER). ON EACH INSTALL, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY - CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER FIRED MALFORMED/UNFORMED STAPLES. NO ERRORS WERE DISPLAYED BY THE SYSTEM. THE STAPLE LINE REPORTEDLY FAILED. MOST OF THE STAPLES WERE UNFORMED OR JAGGED. THE TISSUE WAS SEPARATED. THE SURGEON HAD TO OVERSEW THE STAPLE LINE TO REPAIR THE TISSUE. THE TEAM EXCHANGED THE STAPLER FOR A BACKUP SUREFORM 45 STAPLER AND UPSIZED THE RELOAD. THE CASE CONTINUED WITH NO OTHER REPORTED ISSUES. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A 15-30 MINUTE SURGICAL DELAY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804331 SUREFORM SUREFORM 45 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48345G N/A

    Patients

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