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	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sureform 45 stapler instrument reported in this event was not returned to intuitive surgical, inc.(isi) for failure analysis evaluation.The stapler logs for this procedure were reviewed.The logs show the sureform 45 stapler instrument used during this procedure was installed on the system 14 times and fired 12 sureform 45 reloads (1 blue, 1 green, 1 blue, 1 black, 3 green, 2 black, 1 green, 1 blue, 1 black, in that order).After the successful unclamp on install 14, the system logs showed an error indicating that the grip release tool was detected on the instrument.At the same time, the instrument was force expired by the system.About 20 seconds later, the system logs showed an error indicating that the instrument on universal surgical manipulator (usm) #1 was not detected.The instrument was then removed from the system and not used again in the procedure.
Event or Problem Description
It was reported that during a da vinci-assisted left lower lobe wedge resection procedure, an sureform 45 stapler instrument installed on universal surgical manipulator (usm) #1 would not unclamp after being fired.As a result, the port was upsized to 12 millimeters and changed to usm #4 to finish stapling.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) received medwatch report (mdr) with user facility/importer report #(b)(4) stating: "davinci arm #1 was being used for stapling, but the clamp would not release after being fired.The port was upsized to 12 millimeter and changed to arm #4 to finish stapling." the following information is unknown: how the stapler instrument was ultimately removed, if there was any damage/injury to tissue due to the unclamping issue, and if any surgical intervention was required as a result of the customer reported failure.Isi has attempted to gather additional information regarding the reported event; however, no response has been received.

• 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: 24574847
• Report Number: 2955842-2026-15705
• Device Sequence Number: 18725747
• Product Code: GDW
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)K10250729
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: K10250729 0121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male