MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number	480460-12
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the stapler instrument to perform failure analysis.Stapler logs showed the sureform 60 stapler k17250911-0111 - the stapler being returned - was used first.It was installed on the system 5 times and fired 1 green reload.On install 1, a white reload was installed, however no clamping or firing was attempted.On install 2, a blue reload was installed.The user made 3 incomplete clamp attempts.There was no unclamp attempt following the 3rd incomplete clamp.On install 3, the first two clamp attempts were aborted by the user.The 3rd clamp was successful, and the firing was completed with 3-4 pauses for compression.On install 4, a blue reload was installed, and the only clamp attempt was incomplete.No unclamp was attempted.On install 5, a blue reload was installed and the only clamp attempt was incomplete.No unclamp was attempted.The instrument was then removed and not used in the procedure again.A second stapler k11250219-0162 was then installed on the system six times and fired five reloads (one green, followed by four blue).On installs 1 and 2, the first clamps were successful, and the firings were each completed with 1 pause for compression.On installs 3, 5, and 6, the first clamps were successful, and the firings were completed with no pauses for compression.On install 4, a blue reload was installed, however no clamping or firing was attempted.After install 6, the instrument was removed and not used again in the procedure.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the stapler "could not be opened after the stacking process".During the second fire using the sureform 60 stapler instrument, the jaws of the instrument would not open while stuck on tissue after firing a blue reload.This occurred with the second fire of this stapler instrument.The message "tissue too thick" appeared following an aborted clamp attempt.The tissue was carefully pushed out of the closed jaws with no reports of tissue damage.The procedure was completed as planned.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60
• 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 ; 4085232100
• MDR Report Key: 24686390
• Report Number: 2955842-2026-17571
• Device Sequence Number: 15946692
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)K17250911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 480460-12
• Device Catalogue Number: 480460
• Device Lot Number: K17250911 0111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• 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