MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD WHITE

Model Number	48630W-06
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Firing Problem (4011)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the endowrist 30 white reload accessory to perform failure analysis (fa) and did not confirm or replicate the customer reported complaint.The reload accessory was returned with a partial fire and some of the staples were deployed.It was not returned with an instrument; therefore, the firing failure could not be verified in the logs.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.The reload accessory was attached to an in-house golden instrument and received a used reload error.No product issue was identified.A review of the provided video was performed by an isi clinical development engineer.The following additional information was provided: it can be confirmed that at 38:20, the endowrist 30 mm stapler instrument clamps and begins firing, but experiences a partial fire (firing is halted) before staples are deployed into tissue and before the vessel is cut.The stapler instrument is then removed, reinstalled, and fired again with successful stapling and cutting.The partial fire system behavior is intended to prevent further stapling when the system experiences excessively high firing forces.High firing forces may be caused by very thick or calcified tissue, or due to obstructions (like loose staples from a previous fire) in the firing path.It cannot be confirmed from the video if there were obstructions between the jaws at the time of the partial fire.An advance stapler log review shows the endowrist 30 curved-tip stapler instrument, (lot number: t10240104-0007), was installed on the system 8 times and fired 6 reloads (3 white, followed by 2 green).On installs 1 and 2, a green reload was installed, however no clamping or firing was attempted.On installs 3, 5, 7, and 8, clamping and firing were completed without error.On install 4, the first clamp was successful, but was followed by a firing failure.The logs show an error representing the failure.On install 6, the first 3 clamp attempts were incomplete.The 4th clamp was successful, and the firing was completed without error.After the 8th install, the instrument was removed and not used again in the procedure.There were no additional stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, loose staples fell into the patient¿s surgical site after a firing failure occurred with the endowrist 30 stapler instrument, equipped with a white reload accessory.The firing failure occurred while stapling the pulmonary artery, the surgeon fired over an existing staple line, and a message stating "unable to complete fire, blade may be exposed" was noted.It is unknown if the loose staples were retrieved; however, there was no unplanned tissue removal or bleeding as a result of the event and the procedure was completed robotically.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 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: 21921519
• Report Number: 2955842-2025-16489
• Device Sequence Number: 13017277
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)K10240725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152421
• 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
• Report Date (Section B): 04/03/2025

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: 48630W-06
• Device Catalogue Number: 48630W
• Device Lot Number: K10240725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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: Other
• Patient Sex: Unknown