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

Model Number	480445-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci assisted procedure, a sureform 45 stapler instrument fired a green reload and became stuck on lung tissue.The surgeon had not encountered any obstructions between the instrument's jaws.There was no tissue tension or tissue bunching that occurred.It was reported that the procedure was completed with no patient injury.The surgeon used another stapler instrument to complete the procedure.
Additional Manufacturer Narrative
The sureform 45 stapler was analyzed and the complaint was not confirmed by failure analysis.In-house testing and visual inspection showed no damage.The channel sprang back open when in the unclamped state.The in-house reload attached and removed from the stapler without any issues.The instrument passed the recognition and engagement tests.The reload passed the reload recognition test.The instrument moved intuitively with a 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 proper b-shape.Procedure logs were unable to be retrieved.The instrument was fully functional.There was no problem detected.A review of the system logs was attempted.However, the search did not return any results aligned with the customer-reported product information and/or event date.The image received of this event was reviewed: in the image, the stapler jaws are slightly opened.Tissue is positioned between the jaws, with noticeable attachment of the tissue to the cartridge side of the jaws.Assuming that this image is oriented such that gravity is pointing towards the bottom of the image, and given the minor opening between the jaws, it looked more like tissue sticking to the reload after a fire rather than an intentional grasp.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45
• 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: 23876522
• Report Number: 2955842-2025-49530
• Device Sequence Number: 14620505
• Product Code: GDW
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)K10250829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: K10250829 0355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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 Sex: Unknown