BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 24230899 · Received February 2, 2026

    Report

    Report Number
    2955842-2026-02871
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 23, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117122
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INSTRUMENT; HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 45 WHITE RELOAD WAS ANALYZED AND FOUND TO HAVE THE KNIFE ROTATED WITHIN THE KNIFE TRACK. THE KNIFE WAS ROTATED TOWARDS THE MIDDLE OF THE RETURNED RELOAD. ADDITIONAL OBSERVATION: THE RELOAD WAS FOUND TO HAVE CARTRIDGE DAMAGE IN THE MIDDLE OF THE RELOAD. LOGS SHOW THE SUREFORM 45 STAPLER CURVED TIP, WAS INSTALLED ON THE SYSTEM 8 TIMES AND FIRED 7 RELOADS (1 GREEN, 1 WHITE, 1 GREEN, 3 WHITE, 1 GREEN, IN THAT ORDER). ON INSTALLS 1-3, THE FIRST CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 4, A WHITE RELOAD WAS INSTALLED, HOWEVER NO CLAMPING OR FIRING WAS ATTEMPTED. ON INSTALL 5, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR, AND THE USER MANUALLY SELECTED THE WHITE RELOAD VIA THE GUI ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD, THE FIRST CLAMP WAS SUCCESSFUL, BUT WAS FOLLOWED BY A FIRING FAILURE. THE FIRING STOPPED AT APPROXIMATELY 99%, AFTER A DURATION OF 28 SECONDS. THE MASTER SUPERVISORY CONTROLLER (MSC) LOGS SHOW ERROR 22030 REFERRING TO THE FIRING FAILURE, WHICH MATCHES THE DIGITAL SIGNAL PROCESSOR (DSP) LOGS FIRING FAILURE RECORDED. ON ALL OTHER INSTALLS, THE FIRST CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. AFTER INSTALL 8, THE INSTRUMENT WAS REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THE ROOT CAUSE IS ATTRIBUTED TO A ROTATED KNIFE WITHIN THE KNIFE TRACK, WHICH COULD BE CAUSED BY DIFFERENT FACTORS DURING THE STAPLER FIRING PROCESS, SUCH AS TISSUE CONDITION (E.G., DISEASE STATE AND DENSITY), AND FOREIGN OBJECTS (E.G., METAL CLIPS) THAT CAN CAUSE STAPLER FIRING FORCES TO EXCEED THE PRESCRIBED LIMIT AND SUBSEQUENTLY RESULT IN A PARTIAL FIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, WHILE STAPLING (CUTTING) A BLOOD VESSEL, THE MESSAGE ¿TISSUE TOO THICK TO CONTINUE¿ APPEARED. THE INSTRUMENT WAS REMOVED FROM THE PATIENT BODY, AND WHEN THE RELOAD WAS DETACHED, THE RELOAD¿S KNIFE TRACK WAS FOUND TO BE SHAVED/ABRADED. NO FRAGMENT FELL INTO THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: NO FRAGMENT FELL INTO THE PATIENT¿S BODY, AND THE ABSENCE OF FRAGMENTS WAS CONFIRMED DURING THE PROCEDURE. THERE IS NO INSTRUMENT RETURN. NO IMAGES ARE AVAILABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293809 SUREFORM SUREFORM 45 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48345W-03 K11250403 10886874117122

    Patients

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