MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE

Model Number	430073-05
Medical Device Problem Codes	Material Fragmentation (1261); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the access port; however, intuitive surgical, inc.(isi) has not received the product for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the access port tore in a visible spot.This resulted in a sudden loss of insufflation.The procedure was completed.Intuitive surgical, inc.(isi) contacted the initial reporter and obtained the following information: the access port was not extensively inspected as it was assumed that there were no defects.It was intact at the beginning, as we used it for around 1.5 hours without any problems.The customer opened a new access port to correct the issue.There was no injury to the patient.

• Brand Name: NONE
• Common Device Name: NONE
• 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: 23426518
• Report Number: 2955842-2025-43307
• Device Sequence Number: 8253212
• Product Code: NAY
• UDI-Device Identifier: 10886874119546
• UDI-Public: (01)10886874119546(17)270630(10)K10250619
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202571
• 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
• Report Date (Section B): 10/30/2025

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: 430073-05
• Device Catalogue Number: 430073
• Device Lot Number: K10250619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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