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	Insufficient Information (4580)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that, the sureform 45 stapler instrument had difficulty opening and closing.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The sureform 45 stapler instrument was found to have repeated clamping failures within a single install based on log review.The instrument was functionally tested on an in-house system and achieved adequate compression on a test foam with a green 45 reload installed.The instrument was found to have lodged staples at the channel.There was no visible damage to the instrument.Two staples were found to be lodged inside the channel.The staples were removed.Root cause is attributed to component susceptibility to damage.Intuitive followed up and obtained additional information.There was no unexpected tissue removal.Issue was identified during procedure.It was not known if jaws were stuck on tissue.There was no bleeding observed.No fragment fell in the patient.There was no injury to the patient.Th procedure was completed robotically.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the green sureform 45 reload with an alleged issue to perform failure analysis.Reload was returned unused and unfired.It was not returned with an instrument.A visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The reload was attached to an in-house golden instrument and placed and driven on an in-house system.The reload attached to and removed from the instrument without any issues on multiple attempts.The instrument passed the recognition and engagement tests.The instrument initialized, clamped, fired, and unclamped without any issues using the returned reload.The reload cover was removed and inspected after firing.There was no damage to the reload or its components.No product issue was identified.A review of the information associated with this event has been performed by post market failure analysis engineer (fae) on 21-jan-2026.The following additional information was provided: logs show pn 480445-06, ln k16250605-0172, was installed on the system 4x and fired 3 green reloads.On install 1, there were 5 incomplete clamp attempts, ranging from ~46% to ~68%, linearly.No unclamp was recorded following the 5th incomplete clamp.On install 2, the first clamp was successful, and the firing was completed with 1 pause for compression.On installs 3 and 4, the first clamps were successful, and the firings were each completed with no pauses for compression.The instrument was then removed and not used in the procedure again.There were no stapler related errors in the logs.The probable root cause of the lodged staples is attributed to loose staples from firing across staple lines or not having a full bundle of tissue between the jaws during use.Loose staples that do not go into tissue can be dragged into the i-beam slot as the i-beam retracts during unclamping.Increased drive train friction during calibration due to a staple lodged in the path of the i-beam can prevent the instrument from registering the reload color, which then results in an initialization failure.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23576521
• Report Number: 2955842-2025-45213
• Device Sequence Number: 21179338
• Product Code: NAY
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)K16250605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: K16250605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 12/31/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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