MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. VESSEL SEALER 8 MM; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Catalog Number	480322
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While doing a robotic right hemicolectomy for a mass in the distal ileocecal valve with xi robot, the vessel sealer jaws would not open and another product had to be utilized.

• Brand Name: VESSEL SEALER 8 MM
• Common Device Name: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 8436352
• Report Number: MW5085021
• Device Sequence Number: 14009994
• Product Code: NAY
• UDI-Device Identifier: 00886874112748
• UDI-Public: 00886874112748
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 480322
• Device Lot Number: M11180914
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 76