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

Model Number	410298
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During robotic surgery, the stapler was placed in the robotic arm and it did not work.After about 15 minutes of trouble shooting, it was determined that the motor pack of the stapler device (reusable for 45 uses) did not work.A replacement motor pack was opened and procedure commenced without further issue.Intuitive surgical notified and consulted during troubleshooting.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 9347586
• Report Number: 9347586
• Device Sequence Number: 14109955
• Product Code: NAY
• UDI-Device Identifier: 00886874111093
• UDI-Public: (01)00886874111093
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 10/30/2019
• Report Date (Section F): 10/30/2019

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: 410298
• Device Catalogue Number: 372300
• Device Lot Number: 356736
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 69
• Date Report Sent to FDA: 10/30/2019