MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED-TIP STAPLER 30

Model Number	470530-09
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the jaws of the curved-tip stapler 30 instrument would not open.No fragment fell into the patient.The customer completed the procedure and no known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The curved-tip stapler 30 was analyzed, and the findings did not replicate or confirm the customer reported event.A visual inspection displayed no signs of physical damage.The stapler was tested in-house, and the instrument passed the recognition and engagement tests on three out of three attempts.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly on multiple attempts.The instrument attached to and removed from the arm without any issues on multiple attempts.The instrument was fully functional.The failure analysis investigations and in-house testing of the returned instrument revealed no issues related to the customer reported issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the stapler was being inserted in the trocar and attempting to staple tissue.There was no fault or error noted.The jaws were stuck open, and the end of the instrument would not move/articulate correctly.No tissue was damaged or removed.There was no injury to the tissue, therefore no bleeding.A review of the advanced technical log for the instrument associated with this event has been performed by an isi failure analysis engineer (fae).The following additional information was provided: logs showed the instrument was installed on the system 7x and fired 4 white reloads.On installs 1-3, clamping and firing were completed without error.On installs 4 and 5, the system failed to detect a valid reload in the jaws.Logs showed two instances of error code 1164, representing the two installs.Additionally on install 4, it appeared that the instrument also experienced a shifting failure.Error code 22030 occurred with parameters indicating a shifting failure during the fire homing sequence.On install 6, the user manually selected the white reload color via the user interface on the surgeon side console touchpad.Clamping and firing were then completed without error.On install 7, a white reload was installed, however no clamping or firing was attempted.The instrument was then removed and not used in the procedure again.There were no additional errors pertaining to the use of this stapler in the logs.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED-TIP STAPLER 30
• 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: 23095819
• Report Number: 2955842-2025-38292
• Device Sequence Number: 9503884
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(11)240926(10)T10240926(91)0010
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K152421
• 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,Followup
• Report Date (Section B): 08/25/2025

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: 470530-09
• Device Catalogue Number: 470530
• Device Lot Number: T10240926 0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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