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

Model Number	480445-04
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the logs for the sureform stapler associated with this event has been performed and the following additional information was provided: the logs were not available, so the procedure review dashboard was used to collect data on the installs.Logs show pn 480445-06, ln k13240208-0586, was installed on the system 3x and fired 2 green reloads.On install 1, the first clamp was successful, and the firing was completed with no pauses for compression.On install 2, the system failed to detect the reload color, and the user manually selected the green reload on the surgeon side console (ssc) touchpad.No clamping or firing was attempted.On install 3, the first two clamp attempts were successful, and the firing was 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.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the sureform 45 stapler jaws opened and closed by itself after loading the second reload.The customer was completing the procedure as planned with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the issue occurred with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer.The issue occurred while the surgeon was attempting to manipulate instruments from the surgeon console.The failure was not related to an inability to move the instrument at all.The movements of the surgeon did scale appropriately to the instrument.The instrument moved in the intended direction.The timing of instrument movement was appropriate and there was no collision between the instruments.The issue was intermittent and it was reseated to resolve the issue.The device was inspected prior to use and there was no damage out of the ordinary.
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: 24609318
• Report Number: 2955842-2026-16002
• Device Sequence Number: 9834508
• Product Code: GDW
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)K13240208
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

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: 480445-04
• Device Catalogue Number: 480445
• Device Lot Number: K13240208 0586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 06/05/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/14/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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