MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number	480299
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Condensation was noticed in the tubing of the suction irrigator while it was still in the packaging, prior to opening.A new suction irrigator was retrieved, the contaminated one did not come in contact with the patient.

• Brand Name: ENDOWRIST
• Common Device Name: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 24532242
• Report Number: 24532242
• Device Sequence Number: 8894843
• Product Code: NAY
• UDI-Device Identifier: 00886874114810
• UDI-Public: (01)00886874114810
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/06/2026
• Report Date (Section F): 01/06/2026

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
• Device Model Number: 480299
• Device Catalogue Number: 480299
• Device Lot Number: K16250926
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/06/2026