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

Model Number	470551-07
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a notification appeared stating that the tower touchscreen was not functioning.The filter function also did not work when using energy, making it difficult to maintain visibility.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue was resolved with backup insufflator smoke evacuation.The procedure was completed as planned.They did not use an external suction device instead of the insufflator smoke evacuation.The issue occurred when the smoke evacuation function was turned on after docking.The touchscreen was not functioning.The issue has not recurred since the reported event.The insufflation tubeset was inspected with no damage observed.There was no patient injury or harm.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the tube set associated with this complaint and completed investigations.Failure analysis (fa) investigation confirmed, but did not replicate the customer-reported complaint of the filter function not working.The reported event with the accessory was confirmed, but not replicated.The customer error log was reviewed and found to have "insufflator occlusion" and "insufflator smoke blocked" related to the customer complaint.An error code that indicated "insufflator invalid tube set" was found but was not not related to the customer complaint.Due to these errors, 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 eft inlet port and showed 51.55 at 1.44 psi, which indicated a passing test result.The smoke evacuation line was also tested and passed with a reading of 50.42 slpm at 2.90 psi.The tube set was also plugged into the in-house system and failed recognition.Three out of three attempts showed the same error: "disconnect and replace insufflator tube set.Invalid tube set connected." the accessory was visually inspected but found no damage.There were no blockages, moisture, or tears inside the tubing.The rfid was still present.No product issue was identified.Based on the investigation results, the customer reported issues may be due to other factors unrelated to the product.
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: 25143189
• Report Number: 2955842-2026-24570
• Device Sequence Number: 9325669
• Product Code: HIF
• UDI-Device Identifier: 10886874120696
• UDI-Public: (01)10886874120696(10)PR4041293
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: PR4041293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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