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

Model Number	480322
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During robotic left colectomy, the ligasure device did not burn as it should have when the handle was depressed.Device would not seal.Staff tried (without effectiveness) unplugging, cleaning jaw, and regrasping.A new device was retrieved.There was no harm to the patient.Manufacturer response: for vessel sealer, ligasure device, davinci (per site reporter).The manufacturer is sending a replacement.

• 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: 7717701
• Report Number: 7717701
• Device Sequence Number: 1015390
• Product Code: NAY
• UDI-Device Identifier: 00886874112748
• UDI-Public: (01)00886874112748(17)200331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/07/2018
• Report Date (Section F): 07/10/2018

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: 480322
• Device Lot Number: M11180405
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 102
• Date Report Sent to FDA: 07/10/2018