MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLACK

Model Number	48345T-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, customer fired the stapler, however it stopped midway and a red alert appeared instructing to remove it.After separating it from the robot, the customer tried to remove the cartridge, but it couldn't be removed from the stapler handle.The procedure was completed with no reported injury.Intuitive followed up with the customer and received additional information: issue involved a partial fire.A red alert appeared instructing to remove it.A black reload was being used.A back up was used to resolve the issue.No bleeding observed.No tissue removal, no obstructions.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 45 stapler to perform failure analysis.A visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully using a green 45 reload.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the prop b-shape.Review of the logs were unable to verify any failures.The sureform 45 stapler instrument was fully functional.There was no problem detected.The sureform stapler 45 reload was analyzed and found to have the knife exposed within the knife track.Log review confirms the reload was not involved in a firing failure.The knife was exposed towards the distal end of the returned reload.Visual inspection confirms there is a lodged staple ahead of the blade stopping point, which can prevent the blade from progressing through the full firing trajectory.The reload was found to have cartridge damage.A piece of the cartridge was found wedged in between the reload in front of the exposed knife, causing it to jam.The piece was removed from in between the reload and the shuttle was fully deployed.The knife was inspected and there was damage found.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.There was cartridge damage observed.A blade exposed icon and message would appear if the firing sequence were interrupted.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: SUREFORM 45 RELOAD BLACK
• 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: 24125219
• Report Number: 2955842-2026-01424
• Device Sequence Number: 15877221
• Product Code: NAY
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)N/A
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 48345T-01
• Device Catalogue Number: 48345T
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2019
• 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 Sex: Unknown