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

Model Number	431150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the instrument was grasping tissue and would not ungroup.Troubleshooting was preformed but the surgeon had to cut the tissue that the instrument was grasping in order to remove the instrument from the robot.

• Brand Name: ENDOWRIST SP
• Common Device Name: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 24625853
• Report Number: 24625853
• Device Sequence Number: 12974917
• Product Code: NAY
• UDI-Device Identifier: 00886874124055
• UDI-Public: (01)00886874124055(11)260115(10)K10260115
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/20/2026
• Report Date (Section F): 02/20/2026

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: 431150
• Device Lot Number: K10260115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• 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: 02/20/2026