MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE

Model Number	430075-05
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.The access port kit was inspected and found to have no visible physical damage.The access port kit could not be tested for leakage.No product issue was identified.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer experienced difficulty when maintaining pneumoperitoneum due to a large air leakage from a camera¿s access port kit.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information.The procedure was right hemicolectomy.The access port kit had damage to the valve due to inserting laparoscopy instrument.There was no issues and challenges due to the loss of insufflation.Loss of insufflation was resolved by replacing the instrument.There was no intra-operative and no post-operative complications.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Additional evaluation of the access port kit was conducted.The initial analysis was confirmed; however, the leakage was not confirmed.The returned access port and entry guide were all visually inspected and all components were present as expected and no damage was found.The returned entry guide was installed into the returned access port a was pressurized to 15mmhg.A 5.6mm obturator was inserted through the rotating seal, translated laterally and swept 360-degrees around the opening and no leaks were observed as 15mmhg was able to be maintained and insufflation did not exceed 2slpm.The reported event was not confirmed as failure analysis found no functional issues.The accessory was visually inspected and evaluated for its mechanical characteristics by in-house testing and the investigation revealed no issues related to the customer reported event.

• 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: 22945133
• Report Number: 2955842-2025-36095
• Device Sequence Number: 9781064
• Product Code: NAY
• UDI-Device Identifier: 10886874119553
• UDI-Public: (01)10886874119553(17)270331(10)K10250327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 12/10/2025

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: 430075-05
• Device Catalogue Number: 430075
• Device Lot Number: K10250327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 11/19/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/30/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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