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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of the date of this report, the sureform 60 stapler instrument or the sureform 60 white reload has not yet been received by intuitive surgical, inc.(isi) for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.An advance log review was performed by a failure analysis engineer.Logs showed pn 480460-12, ln k18251010-0288, was installed on the system 8x and fired 8 reloads (1 blue, 1 white, 1 blue, 5 white, in that order).On each install, all clamps were successful.On installs 1, and 3-5, the firings were each completed with no pauses for compression.On install 2, the firing failed at 51% completion, after a duration of 45 seconds.On installs 6-8, the firings were each completed with 1 pause for compression.After the 8th install, the instrument was removed and not used in the procedure again.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 60 stapler instrument stopped mid-fire, and an error message appeared.The surgeon was able to release the tissue being divided and the bedside assist removed the stapler from the cannula.The defective staple load was removed from the jaws of the stapler.The procedure was completed with no reported injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
As of the date of this report, the sureform 60 stapler has not yet been received by intuitive surgical, inc.(isi) for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.The sureform 60 white reload was found to have the knife exposed within the knife track.The returned reload was found to be partially fired based on in-house visual inspection.No information was provided regarding the sureform stapler used; therefore, no logs are available for review at this time.The knife was exposed towards the middle of the returned reload.No cartridge damage was observed during visual inspection.The event caused partially or wholly by the user of the device including sample handling.Additional observation(s) related to customer reported complaint: the reload blade was found to have mechanical indentations.The reload cover was removed, the shuttle was pulled forward to allow access to the knife, and the knife was inspected.Damage was found to the blade.The event caused partially or wholly by the user of the device including sample handling.The probable root cause of the exposed component can be attributed to various factors.These factors may include instrument damage, particularly in the wrist area, 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.

• 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: 24903612
• Report Number: 2955842-2026-21750
• Device Sequence Number: 9056925
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)K18251010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480460-12
• Device Catalogue Number: 480460
• Device Lot Number: K18251010 0288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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.
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White