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	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery, the suction irrigator stopped functioning.It was replaced with another instrument, and the new suction irrigator was not engaging.The robot was giving an error message.The next suction irrigator used was functioning normally.No patient harm.

• Brand Name: ENDOWRIST
• Common Device Name: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 24924855
• Report Number: 24924855
• Device Sequence Number: 9153336
• Product Code: NAY
• UDI-Device Identifier: 00886874114810
• UDI-Public: (01)00886874114810(11)260115(17)290131(10)K12260115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026
• Report Date (Section F): 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: 480299
• Device Catalogue Number: 480299
• Device Lot Number: K12260115
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2026
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 40 KG
• Date Report Sent to FDA: 04/07/2026