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	03/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The davinci stapler would not release from the instrument arm while in the patient.Eventually, the entire port, stapler, and instrument arm were removed from use.Once the arm was disengaged, the defective stapler was able to be removed from the instrument arm.No harm to the patient.The davinci online support was called to help trouble shoot.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1090 kifer road; sunnyvale CA 94086
• MDR Report Key: 8535269
• Report Number: 8535269
• Device Sequence Number: 2458380
• Product Code: NAY
• UDI-Device Identifier: 00886874111093
• UDI-Public: (01)00886874111093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/09/2019
• Report Date (Section F): 04/09/2019

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 Lot Number: T10181101289
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1
• Patient Weight: 97
• Date Report Sent to FDA: 04/09/2019