MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; SUCTION IRRIGATOR

Model Number	480299-06
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The suction irrigator product was analyzed and the complaint was not confirmed by failure analysis.Failure analysis could not verify the customer reported event.The instrument was tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The suction and irrigation buttons worked properly.The instrument was fully functional.No product issue was found.Based on the investigation results, customer reported issues may be due to other factors unrelated to the product.The probable root cause cannot be determined based on the information provided and failure analysis results.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon and staff could not deactivate suction.The customer reported there was a loss all pneumo during the procedure.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: SUCTION IRRIGATOR
• 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: 24906472
• Report Number: 2955842-2026-21892
• Device Sequence Number: 13033015
• Product Code: NAY
• UDI-Device Identifier: 10886874114817
• UDI-Public: (01)10886874114817(10)K11250626
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 480299-06
• Device Catalogue Number: 480299
• Device Lot Number: K11250626 0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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