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

Model Number	48345W-03
Medical Device Problem Codes	Material Fragmentation (1261); Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Additional information: intuitive surgical, inc.(isi) did receive the sureform 45 curved-tip stapler instrument for failure analysis but was unable to confirm or replicate the customer-reported issue that a partial fire occurred leading to the deployment of unformed staples.Visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument passed the recognition and engagement tests, and moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully twice using a green sureform 45 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.The instrument was fully functional.There was no problem detected.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the white sureform 45 reload to perform failure analysis and was able to confirm and replicate the customer reported complaint.The stapler reload was found to have the knife exposed within the knife track.The knife was exposed towards the middle part of the returned stapler reload.Additionally, the stapler reload was found to have cartridge damage.A piece of the cartridge was found wedged in between the stapler reload, in front of the exposed knife, causing it to jam.The piece was removed, and the shuttle was fully deployed.The knife was inspected and there was damage found.The stapler reload blade was found to have mechanical indentations.The reload cover was removed, the shuttle was pulled forward to allow access to the knife, and the knife was inspected.Damage was found to the blade.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Isi also receive the sureform 45 curved-tip stapler instrument to perform failure analysis and the results are pending investigation.Isi received a video clip related to the alleged complaint.A review of the video clip was conducted by an isi clinical development engineer (cde), and the following additional information was provided: at one point during the video clip, a sureform 45 curved stapler instrument is installed with a white sureform 45 reload, but the system reads it as a blue sureform 45 reload.Based on the video alone the cause of the partial fire cannot be determined.The stapler instrument is then clamped and fired.A partial fire occurs at 30mm.When the stapler is unclamped, it appears that part of the vessel has been stapled but no transection occurred.There does appear to be some unformed staples towards the distal end of the fire.A stapler log review shows the sureform 45 curved-tip stapler instrument, (lot #k14240327-0370) was installed on the system 5 times and fired 5 stapler reloads (1 white, 1 green, 1 blue, 2 black, in that order).On installs 1, 2, and 5, the first clamp was successful, and the firings were each completed with no pauses for compression.On install 3, the first clamp was successful, but was followed by a firing failure.The firing stopped at approximately 59% completion.On install 4, the system failed to detect the stapler reload color, and the user manually selected the black stapler reload color via the surgeon side console (ssc) touchpad.The first clamp was successful, and the firing was completed with no pauses for compression.After the 5th install, the instrument was 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 right middle pulmonary lobectomy procedure, a partial fire occurred on the pulmonary artery when the surgeon fired a white sureform 45 reload with a sureform 45 curved-tip stapler instrument.When the event occurred, an error message was observed stating ¿tissue too thick to continue.¿ the event resulted with the deployment of unformed staples that were partially stuck in tissue.The surgical team then prepared to switch to an open approach, but they managed to successfully unclamp and remove the stapler instrument from the patient.Upon inspection, the white sureform 45 reload revealed that the staples in the initial third of the cartridge were correctly formed in a b-shape, whereas the remaining staples were u-shaped.The tips of the unformed staples, which had fallen out of the cartridge, were partially stuck in the pulmonary artery tissue and were retrieved utilizing a long bipolar forceps instrument during the procedure.This event did not result in any bleeding, as the stapler deployed the staples without cutting the tissue.A third-party stapler instrument was then used to complete the staple line, and the procedure was completed robotically without injury to the patient.

• 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: 22011302
• Report Number: 2955842-2025-20171
• Device Sequence Number: 14759431
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(17)271031(10)K10241010
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345W-03
• Device Catalogue Number: 48345W
• Device Lot Number: K10241010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown