MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. Endowrist; System, surgical, computer controlled instrument

Model Number	480422
Medical Device Problem Codes	Retraction Problem (1536); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: vessel sealer abruptly stopped cutting.Error message stated the blade was still exposed upon removal.Sharp has been wrapped with a surgical towel and taped.Item removed from the field, new one opened.From operative report:.

• 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: 50914824
• Report Number: 50914824
• Device Sequence Number: 17580802
• Product Code: NAY
• UDI-Device Identifier: 00886874115664
• UDI-Public: (01)00886874115664
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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): 09/02/2026
• Report Date (Section F): 09/02/2026

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: 480422
• Device Catalogue Number: 480422
• Device Lot Number: K10260619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• 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: Female
• Patient Weight: 203 LB
• Date Report Sent to FDA: 09/02/2026