MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SureForm; SureForm 45 Curved-Tip

Model Number	480545-06
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, a curved-tip sureform 45 stapler instrument would jerk after completing a fire.This complication occurred during the second stapler fire of the procedure.When the stapler was being fired, the stapler instrument ¿jerked¿ and tore the pulmonary artery (pa).The clinical sales representative (csr) later talked to the doctor¿s first assist who said that they controlled the bleeding during this procedure by stapling the pa.The patient reportedly did well.The surgeon indicated that in his experience, it is normal for the da vinci stapler to ¿jerk¿ while firing.The surgeon said that the jerking movement was not abnormal and it was not a malfunction of the instrument, but that he doesn¿t like that it moves because it can damage sensitive tissue.The procedure was completed robotically.A technical support engineer (tse) reviewed the logs for the case and did not see any errors associated with the reported issue.
Additional Manufacturer Narrative
The status of the curved-tip sureform 45 stapler instrument used during this event is unknown.An intuitive surgical, inc.(isi) field service engineer (fse) completed a system test drive and was unable to reproduce the issue.The system was tested and verified as ready for use.The technical support engineer (tse) reviewed the logs and did not see any errors associated with the reported issue.The stapler logs for this procedure were reviewed.The logs show curved-tip sureform 45 stapler instrument part number (b)(4), lot number k12260507-0412, was installed on the system 11 times and fired 11 reloads (5 white, 4 blue, 1 green, 1 blue, in that order).On install 1, the system failed to detect the reload color and the user manually selected the white reload via the graphic user interface (gui) on the surgeon side console (ssc) touchpad.On installs 1-4, the first clamps were successful, and the firings were each completed with no pauses for compression.On install 5, the first clamp was incomplete.The next clamp was successful, and the firing was completed with 5-6 pauses for compression.On install 6, the first clamps were successful, and the firing was completed with no pauses for compression.On install 7, the first clamps were successful, and the firing was completed with 1-2 pauses for compression.On install 8, the first clamp was successful, and the firing was completed with no pauses for compression.On install 9, the first clamp was successful, but was followed by a firing failure.On install 10, the first clamp was successful, and the firing was completed with 5-6 pauses for compression.On install 11, the first clamp was 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 system logs.

• Brand Name: SureForm
• Common Device Name: SureForm 45 Curved-Tip
• 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 ; +1(408)523-2100
• MDR Report Key: 50192809
• Report Number: 2955842-2026-34913
• Device Sequence Number: 15924667
• Product Code: GDW
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)K12260507
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K12260507 0412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown