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	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The entry guide and the access port were inspected and found to have no visible physical damage.The wound retractor of the access port was not returned.The access port could not be tested for pressure during initial failure analysis.Root cause may be due to other factors unrelated to the product.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the access port wound retractor had decreased abdominal pressure during forceps insertion and inability to maintain abdominal pressure.A backup same da vinci accessory was used for the procedure.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive followed up and obtained additional information.It resulted in sudden/rapid of insufflation.There was 15-20 minute delay.There was no intra-operative complication.Insufflation was resolved by exchange.There was no patient injury due to the event.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) performed advance failure analysis (afa) of the access port kit.The initial analysis was not confirmed.The access port was found to have a leak at the rotating seal.The returned entry guide was installed into the returned access port and was pressurized to 15mmhg.A 5.6mm obturator was inserted through the rotating seal, translated laterally and swept 360 degrees around the opening and a leak was observed when the obturator was at the 6 o¿clock position with respect to the 5-12mm label.The insufflator's flow setpoint was set to 20 slpm and with the obturate at this leaking position, the insufflator was unable to exceed 3mmhg while flowing 20slpm.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The leak at the rotating seal was investigated further.The access port chamber was transferred to design engineering and was ct scanned.Design engineering supplied the following findings: "the results show a misplaced septum and duckbill inside.The cause of the pressure drop observed while lap instruments were held at the 6 o¿clock position was most likely due to the inability of the septum puck assembly to traverse to the 6 o¿clock position due to a misplaced duckbill.The puck contacts the duckbill, stops, and then the septum cat-eyes and insufflation is lost.".
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23019661
• Report Number: 2955842-2025-37463
• Device Sequence Number: 10038428
• Product Code: NAY
• UDI-Device Identifier: 10886874119553
• UDI-Public: (01)10886874119553(17)270430(10)K10250403
• 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,Followup
• Report Date (Section B): 04/07/2026

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: 430075-05
• Device Catalogue Number: 430075
• Device Lot Number: K10250403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 11/19/2025; 03/12/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/30/2025; 12/11/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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