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

Model Number	470430
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of a robotic-assisted lung resection, the da vinci surgical stapler would not open after stapling the tissue.The da vinci surgical system representative was called and the device was unlocked with a key.There was no harm to 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: 10028361
• Report Number: 10028361
• Device Sequence Number: 14376694
• Product Code: NAY
• UDI-Device Identifier: 00886874112700
• UDI-Public: (01)00886874112700
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/28/2020
• Report Date (Section F): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470430
• Device Catalogue Number: 470430
• Device Lot Number: T10190109 0005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75
• Date Report Sent to FDA: 04/28/2020