BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22133225 · Received June 3, 2025

    Report

    Report Number
    2955842-2025-22711
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 6, 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
    WI, 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. AN ADVANCED STAPLER LOG INVESTIGATION BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE) REVEALED THE FOLLOWING: LOGS SHOW THE SUREFORM 60 STAPLER WAS INSTALLED ON THE SYSTEM 2 TIMES AND FIRED 1 BLUE RELOAD. ON INSTALL 1, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR AND THE USER MANUALLY SELECTED THE BLUE RELOAD VIA THE USER INTERFACE ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD. NO CLAMPING OR FIRING WAS ATTEMPTED. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE 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 SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE BLUE SUREFORM 60 RELOAD "UNZIPPED" POSTOPERATIVELY, REQUIRING UNSPECIFIED INTERVENTION. THE BLUE RELOAD APPEARED TO HAVE UNZIPPED RIGHT DOWN THE MIDDLE OF THE STAPLE LINE AND HAD 1/2 CM OF DISCONTINUED STAPLES. DURING THE INITIAL PROCEDURE, A NON-RECOVERABLE FAULT OCCURRED PRIOR TO THE USE OF THE SUREFORM 60 STAPLER INSTRUMENT, AND THE SYSTEM POWERED BACK UP WITHOUT ERRORS AFTER A HARD POWER CYCLE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT IS CURRENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. 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
    358725 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B N/A

    Patients

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