BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22743862 · Received August 7, 2025

    Report

    Report Number
    2955842-2025-32220
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    July 14, 2025
    Report Date
    December 15, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K211997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2 AND H11. ADDITIONAL INFORMATION: THE SUREFORM 30 STAPLER INSTRUMENT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. A VISUAL INSPECTION OF THE DISTAL END WAS PERFORMED AND NO PHYSICAL DAMAGE WAS FOUND. THE RETURNED INSTRUMENT WAS INSPECTED AND FOUND TO HAVE BEEN REPROCESSED PRIOR TO RETURN, WHICH CAUSED THERMAL WARPING OF THE LOWER CHASSIS AND LOOSE STEERING CABLES. THESE CONDITIONS PREVENTED SYSTEM TESTING BUT OCCURRED AFTER THE PROCEDURE AND ARE NOT CONSIDERED RELATED TO THE BLEEDING EVENT. THE INSTRUMENT JAWS WERE DISASSEMBLED, AND TWO STAPLES WERE FOUND LODGED IN THE KNIFE SLOT OF THE ANVIL. THESE STAPLES WERE FORMED BUT TOO LARGE TO ORIGINATE FROM A GRAY RELOAD. LODGED STAPLES CAN OCCUR WHEN FIRING ACROSS PREVIOUS STAPLE LINES OR WHEN THE JAWS DO NOT CAPTURE THE ENTIRE TISSUE BITE. THIS IS CONSIDERED A SUSCEPTIBILITY ISSUE AND IS NOT BELIEVED TO HAVE CONTRIBUTED TO BLEEDING AT THE STAPLE LINE. THE DISASSEMBLED ANVIL WAS INSPECTED USING MICROSCOPE FOR STAPLE MARKS FOR THE PRESENCE OF TITANIUM OR LACK OF FLUORINE, INDICATING A STAPLE PASS. THESE METHODS WERE ABLE TO DETERMINE THAT AT LEAST ONE STAPLE HAD PASSED IN THE RELEVANT POCKETS BUT ULTIMATELY LACKED THE RESOLUTION TO DETERMINE IF TWO STAPLES HAD PASSED THROUGH THE POCKETS. UPON REASSEMBLY, THE INSTRUMENT WAS ABLE TO SUCCESSFULLY INSTALL A GREY RELOAD, AND FIRE ALL STAPLES ONTO A TEST SHEET WHEN ADVANCED BY HAND. THIS MANUAL FIRE DEPLOYED ALL STAPLES WITH NO MALFORMATIONS.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2 AND H11. ADDITIONAL INFORMATION: INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT ASSOCIATED WITH THIS COMPLAINT FOR FAILURE ANALYSIS EVALUATION. A VISUAL INSPECTION OF THE DISTAL END WAS PERFORMED AND NO PHYSICAL DAMAGE WAS FOUND.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE STAPLER LOGS SHOWED A SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT WAS USED FIRST, AND IT WAS INTERMITTENTLY INSTALLED ON THE SYSTEM 3 TIMES AND FIRED 2 GRAY SUREFORM 30 RELOADS. ON INSTALL 1, A GRAY STAPLER RELOAD WAS INSTALLED; HOWEVER, NO CLAMPING OR FIRING WAS PERFORMED. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 3, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. AFTER THE 3RD INSTALL, THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. NEXT, LOGS SHOW A SUREFORM 45 STAPLER INSTRUMENT WAS INSTALLED ON THE SYSTEM 1 TIME AND FIRED 1 BLUE SUREFORM 45 RELOAD. ON THE ONLY INSTALL, 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. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS. ISI RECEIVED VIDEO CLIPS RELATED TO THE ALLEGED COMPLAINT. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE VIDEO SHOWS A NOMINAL FIRE. THERE ARE NO OBSERVED INSTRUMENT OR CLINICAL ISSUES RESULTING FROM THIS FIRE. THE STAPLE LINE APPEARS NOMINAL, AND THERE IS NO APPARENT BLEEDING OR INJURY TO PATIENT TISSUE. ANOTHER VIDEO CLIP SHOWS A FIRE THAT APPEARS TO PROCEED NORMALLY WITH NO PAUSING OR ERROR MESSAGING. UPON COMPLETING THE FIRE AND RELEASING THE STAPLER FROM THE VESSEL, THE STAPLED VESSEL IMMEDIATELY BEGINS TO BLEED. THE VIDEO ENDS SHORTLY AFTER THE BLEEDING OCCURS, BUT THE SURGEON CAN BE SEEN USING SURGICAL GAUZE TO STOP THE ACTIVE BLEEDING. IN REVIEWING THE VIDEO AND CURRENTLY AVAILABLE LOG DATA, A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE STAPLE LINE BLED WHERE A GRAY SUREFORM 30 RELOAD WAS FIRED WITH A SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT. DURING THE SECOND FIRING SEQUENCE WITH A GRAY SUREFORM 30 RELOAD ON THE PULMONARY VEIN, THE STAPLE LINE HAD MISSING STAPLES ALONG THE LEFT SIDE OF THE STAPLE LINE, RESULTING WITH BLEEDING. THERE WERE NO ERROR MESSAGES DURING THE FIRING SEQUENCE. ADDITIONALLY, THERE WAS NO TISSUE TENSION, BUNCHING, OR MALFORMED STAPLES. NO ADDITIONAL TISSUE WAS RESECTED DUE TO THE EVENT. THERE WERE NO REPORTED ISSUES DURING INSTALLATION OF THE STAPLER RELOADS. THE BLEEDING WAS ABLE TO BE CONTROLLED; HOWEVER, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE BLEEDING STAPLE LINE. THE PATIENT REPORTEDLY TOLERATED THE CONVERSION WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411069 SUREFORM 8MM STAPLER GDW INTUITIVE SURGICAL, INC 48230M N/A

    Patients

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