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

Model Number	48630W-05
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the stapler 30 white reload to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The reload was found to have the knife exposed within the knife track.Log review confirms the reload was involved in a firing failure.The knife was exposed towards the proximal end of the returned reload, which aligns with the firing completion percentage displayed in the procedure logs.A blade exposed icon and message will appear if the firing sequence is interrupted.The probable root cause of the exposed component can be attributed to various factors.These factors may include instrument damage, particularly in the wrist area, tissue condition (e.G., disease state and density), and foreign objects (e.G., metal clips) that can cause stapler firing forces to exceed the prescribed limit and subsequently result in a partial fire.A provided image is consistent with the allegation of an exposed blade.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, a stapler 30 white reload was installed on a curved-tip stapler 30 instrument and the stapler fire could not be completed.The user was attempting to staple the pulmonary vessels and no clamping other than the pulmonary vessels was allowed.On the first stapler fire, the blade stopped in the middle of the reload.On the second stapler fire, the blade did not run, and the stapler fire failed.On the third stapler fire, it was performed using a curved-tip stapler 30 instrument prepared separately from the first and second stapler fires, but the blade stopped in the middle of the reload: the same as the first occurrence.The surgeon informed that the sound of operation during the staple fire was different from usual and sounded like a creaking sound.The user completed the procedure, and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the first to third stapler fire was involved with the reported event.The stapler instrument did not work at all.Stapling fire was being performed at the time of the event.The target tissue was the vessel.The tissue was not calcified.There was no tissue tension.There was no tissue bunching.The first time, the fire was stopped before reaching the target's blood vessel, the second time the blade did not move and the fire was stopped, and the third time, although the target's blood vessel was stapled, the fire stopped once it passed the blood vessel and was stopped.The event involved a partial fire.The event did not involve tissue being pushed forward/dragged during the firing process.The event involved the stapler jaws opening/releasing during the firing sequence.There were unformed staples.The event involved the reload having an exposed blade.Staples were not missing from the staple line.There were no holes/gaps observed within the staple line.The reload was not stuck to tissue.A blade may be exposed error was generated when the stapling issue occurred.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.The surgeon did not fire over an existing staple line.Buttress material was not used.The surgeon did not experience any clamping issues prior to firing the stapler reload.There was not any bleeding observed on the staple line due to the stapler issue.
Additional Manufacturer Narrative
The curved-tip stapler 30 instrument was returned and evaluated by the failure analysis (fa) team.Fa was not able to confirm nor reproduce the reported complaint of the initial movement was hard and it stopped halfway.Visual inspection displayed no signs of physical damage.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully using a white 30 endowrist 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 passed the recognition and engagement tests on 3 of 3 attempts.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument attached to and removed from the arm without any issues on multiple attempts.Review of the logs were unable to verify any failures.The instrument was fully functional.There was no problem detected.Issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22572463
• Report Number: 2955842-2025-31040
• Device Sequence Number: 15898802
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)K10240327
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48630W-05
• Device Catalogue Number: 48630W
• Device Lot Number: K10240327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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
• Patient Sex: Unknown