MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SureForm; STAPLER 60 RELOAD GREEN

Model Number	48360G-10
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, lung parenchyma tissue was pushed out of the jaws of a sureform 60 stapler instrument equipped with a sureform 60 green reload.After unclamping, the tissue appeared torn and the staple line was poorly formed.A malformed staple was also observed lodged in the blade track or groove of the stapler reload.The surgeon suspected the stapler reload may have become obstructed by a staple after firing across an existing staple line.No bleeding occurred; however, additional tissue excision was required.The issue was resolved by switching to a sureform 60 black reload, and the procedure was completed robotically.The patient had no postoperative complications, there is no concern for long-term complications related to the event, and the patient has been discharged.
Additional Manufacturer Narrative
Device evaluation: intuitive surgical, inc.(isi) received the sureform 60 green reload for failure analysis evaluation.Visual inspection confirmed the stapler reload had fully fired, and 2¿3 loose staples were found lodged/stuck in front of the knife.These staples can prevent progression of the knife travel and from completing the full firing trajectory.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the sureform 60 green reload to perform failure analysis.A review of the stapler log shows that sureform 60 stapler instrument (lot number: k13250821-0306), was installed on the system 9 times and fired 8 stapler reloads (7 green, followed by 1 black).On installs 1-5, and 7, the first clamps were successful, and the firings were each completed with no pauses for compression.On install 6, a green stapler reload was installed; however no clamping or firing was attempted.On install 8, the first clamp was incomplete; however, the next clamp was successful, and the firing was completed with 7 pauses for compression.On install 9, the first clamp was incomplete, but the next clamp was successful, and the firing was completed with 4 pauses for compression.There were no stapler related errors in the system logs.A review of the customer-provided image shows that a sureform 60 green reload that has been fired.The knife is exposed and visible at the distal end of the knife track.There are multiple malformed staples trapped near the knife blade.All pushers appear to be deployed signaling that the staples were deployed along the length of the fire.Based on the image review alone, it could not be confirmed whether or not this was a tissue pushout event.A review of the customer-provided video shows that, at approximately 15:18, a 8mm sureform 30 stapler instrument is installed on universal surgical manipulator (usm) #4 and successfully completes a fire using a whiter stapler reload.Dissection then continues until approximately 22:04, when a sureform 60 stapler instrument with a green stapler reload is installed on usm #4.The stapler instrument is immediately removed and reinstalled, after which the guided user interface (gui) prompts the surgeon to select the stapler reload color.The stapler instrument is positioned on lung parenchyma that is covered with numerous previously formed loose staples.With tissue fully seated between the jaws, the fire completes successfully without pauses for compression.The stapler instrument is removed, and the resulting staple line appears intact.A second sureform 60 green reload is then installed to extend the previous parenchyma fire.The stapler instrument is fired, and pauses at approximately 54mm, 49mm, 30mm, 24mm, 18mm, and 13mm remaining.The stapler instrument is then unclamped and removed from tissue, revealing a deposit of unformed and malformed staples bunched in one area.There is an unspecified amount of bleeding originating from the general cluster of staples, and the tissue is not fully approximated.A sureform 60 stapler instrument with a black stapler reload is then installed and positioned near the incomplete staple line.The stapler instrument is fired and pauses at approximately 60mm, 56mm, 48mm, and 40mm remaining.Based on what is visible, the resulting staple line appears complete and properly formed.A small amount of tissue is still intact at the very distal end of the staple line and is transected using a force feedback maryland bipolar forceps instrument and bipolar energy.The specimen is then retrieved, and no further stapling is performed.

• Brand Name: SureForm
• Common Device Name: STAPLER 60 RELOAD GREEN
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; +1(408)523-2100
• MDR Report Key: 50122706
• Report Number: 2955842-2026-34174
• Device Sequence Number: 5636649
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(17)281130(10)K10251106
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 48360G-10
• Device Catalogue Number: 48360G
• Device Lot Number: K10251106
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown