MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number	470298-14
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tips of stapler 45 instrument would not open.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The stapler 45 instrument was analyzed, and the complaint was not confirmed by failure analysis.A visual inspection found no damage.The instrument was tested on an in-house system and found the instrument clamped, unclamped and fired successfully.The instrument moved intuitively with full range of motion in all directions.The logs were not displayed.The instrument was unused and fully functional.No product issue was found.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up and obtained additional information.The technicians are trained to inspect instruments during assembly for cleanliness and functionality before sterilization.The staff was hopeful that this happened.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• 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: 24196014
• Report Number: 2955842-2026-02018
• Device Sequence Number: 7976165
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10220527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• 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): 02/13/2026

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: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10220527 0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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