MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TUBE SET WITH SMOKE EVACUATION

Model Number	470551-07
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the abdominal pressure suddenly dropped to zero during surgery and could not be increased.After that the pressure was set to the set pressure and kept it.The technical support engineer (tse) advised checking the hoses, connectors and settings.Then, they found the issue occurred when a surgeon was using a vacuum machine.The tse explained that was the most likely cause, so advised adjusting the flow rate or set pressure higher.After the first call, the issue still persisted, so they replaced the tube set and then the issue was completely resolved.The tse advised to return the original one.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the da vinci product with an alleged issue to perform failure analysis; however, the investigation is in progress.A follow-up mdr will be submitted when the product is evaluated and/ or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the insufflator tube set to perform failure analysis.Failure analysis investigations did not replicate nor confirm the customer reported complaint with the tube set.Due to the complaint, the tube set flow test was performed to measure the flow capability of the insufflation and smoke evacuation lines of a tube set.The insufflation line was connected to the inlet port and showed 50.20 slpm at 1.43 psi, which indicated a passing test result.The smoke evacuation line was also tested and passed with a reading of 48.60 slpm at 2.89 psi.The accessory was visually inspected, but no damage was found.There was no sudden drop in pressure observed during the test.The pressure/air flow remains consistent.No product issue was identified.Further investigation confirmed the accessory had recognition failure.The accessory was placed on the in-house system, and an error message, "disconnect and replace insufflator tube set.Invalid tube set connected." appeared on the tower screen.The accessory was placed on the system five times, but the same message appeared on the screen.The customer error log was retrieved, but there was no error found.The event log was checked at the in-house system, but the error appeared not to have been recorded on the system.The radio frequency identifier (rfid) was present.The accessory was found to have white scuff marks on both sides of the filter cartridge.The tubes were inspected and found to have no damage.The release latches are functional.The veress adapter found no damage.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: TUBE SET WITH SMOKE EVACUATION
• 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: 24706784
• Report Number: 2955842-2026-18681
• Device Sequence Number: 16062238
• Product Code: HIF
• UDI-Device Identifier: 10886874120696
• UDI-Public: (01)10886874120696(10)LU4037771
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 470551-07
• Device Catalogue Number: 470551
• Device Lot Number: LU4037771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 06/02/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/16/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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