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

Model Number	470530-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.This report is a related record of another complaint.Please refer to the report with mfr report number 2955842-2025-38628 for details regarding the other curved-tip 30 stapler instrument that was used in the same procedure.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the curved-tip 30 stapler instrument got stuck while being used since it had sutured and cut half the length to be sutured.The customer replaced the curved-tip 30 stapler instrument with a back-up instrument of the same kind, which encountered the same problem, but the surgeon was able to complete the stapling and cutting with this instrument.There was no patient harm, adverse outcome, or injury.Intuitive surgical (is) contacted the site and obtained the following additional information regarding this event: the instrument was inspected prior to use with no damage found.The reported issue involved a green stapler reload, selected for its clinical suitability, during the first stapler fire in a segmental lung resection targeting the bronchus.There was no calcification, radiation, chemotherapy exposure, tissue tension, or bunching.The issue was a partial fire, resulting in an exposed blade and missing staples from the staple line, but no malformed staples, unexpected staple deployment, or gaps were observed.The reload was not stuck to tissue.There were no obstructions, prior staple lines, buttress material, or clamping issues.No bleeding was noted, and no unplanned tissue removal occurred.No material detached or fell inside the patient.The procedure was completed robotically without patient injury, although there was a 15-minute delay.

• 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: 23100301
• Report Number: 2955842-2025-38629
• Device Sequence Number: 15624719
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(11)240104(10)T12240104
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 470530-08
• Device Catalogue Number: 470530
• Device Lot Number: T12240104 0019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• 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