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

Model Number	48345W-03
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the sureform 45 white reload staple line was incomplete, causing a leak.It is unknown what intervention was required to address the leak.The procedure was completed robotically.Intuitive surgical, inc.(isi) has attempted to obtain additional information; however, as of the date of this report, no further details have been received.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received three sureform 45 white reloads associated with this complaint.Failure analysis did not confirm the reported event.All three reloads were returned unused and unfired.It was not returned with an instrument.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The reloads were attached to an in-house golden instrument and placed and driven on an in-house system.The reloads were attached to and removed from the instrument without any issues on multiple attempts.The instrument passed the recognition and engagement tests.The reload passed the reload recognition test.The instrument initialized, clamped, fired, and unclamped without any issues using the returned reload.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.No product issue was identified.Sureform 45 stapler logs show that the instrument was installed on the system 12 times and fired 12 reloads (1 green, 3 white, 5 blue, 1 white, 2 blue, in that order).On installs 1-11, the first clamp was successful, and the firings were each completed with no pauses for compression.On install 12, the system failed to detect the reload color, and the user manually selected the blue reload via the user interface on the surgeon side console (ssc) touchpad.The first two clamp attempts were incomplete.The 3rd clamp was successful but was followed by a firing failure.The instrument was then removed and not used in the procedure again.There were no stapler related errors in the logs.

• 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: 24847766
• Report Number: 2955842-2026-21223
• Device Sequence Number: 14865674
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(10)K10250415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: 48345W-03
• Device Catalogue Number: 48345W
• Device Lot Number: K10250415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White