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	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the curved tip stapler instrument; however, failure analysis investigations are under progress.A follow-up mdr will be submitted the instrument had been evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the jaws of curved tip stapler instrument would not open.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The 30 degrees curved tip stapler instrument was analyzed and found to the instrument passed the recognition and engagement tests on 3 of 3 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 stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully twice using two white 30 reloads.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 use of the irk was not necessary.Review of the procedure logs could not confirm any failures.The instrument was fully functional.There was no problem detected.The complaint regarding the jaws will not open was not confirmed by failure analysis.The probable root cause cannot be determined based on the information provided and failure analysis results.
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: 24007398
• Report Number: 2955842-2026-00418
• Device Sequence Number: 17330017
• 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): 02/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470530-09
• Device Catalogue Number: 470530
• Device Lot Number: T10240926 0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/11/2026
• 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: 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