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

Model Number	48345W-03
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, while stapling (cutting) a blood vessel, the message ¿tissue too thick to continue¿ appeared.The instrument was removed from the patient body, and when the reload was detached, the reload¿s knife track was found to be shaved/abraded.No fragment fell into the patient¿s body.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following information: no fragment fell into the patient¿s body, and the absence of fragments was confirmed during the procedure.There is no instrument return.No images are available.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the instrument; however, intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 45 white reload was analyzed and found to have the knife rotated within the knife track.The knife was rotated towards the middle of the returned reload.Additional observation: the reload was found to have cartridge damage in the middle of the reload.Logs show the sureform 45 stapler curved tip, was installed on the system 8 times and fired 7 reloads (1 green, 1 white, 1 green, 3 white, 1 green, in that order).On installs 1-3, the first clamps were successful, and the firings were each completed with no pauses for compression.On install 4, a white reload was installed, however no clamping or firing was attempted.On install 5, the system failed to detect the reload color, and the user manually selected the white reload via the gui on the surgeon side console (ssc) touchpad, the first clamp was successful, but was followed by a firing failure.The firing stopped at approximately 99%, after a duration of 28 seconds.The master supervisory controller (msc) logs show error 22030 referring to the firing failure, which matches the digital signal processor (dsp) logs firing failure recorded.On all other installs, the first clamps were successful, and the firings were each completed with no pauses for compression.After install 8, the instrument was removed and not used in the procedure again.The root cause is attributed to a rotated knife within the knife track, which could be caused by different factors during the stapler firing process, such as 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 WHITE
• 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: 24230899
• Report Number: 2955842-2026-02871
• Device Sequence Number: 21077842
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(17)280430(10)K11250403
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 48345W-03
• Device Catalogue Number: 48345W
• Device Lot Number: K11250403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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