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

Lot Number	M11180426
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Davinci xi instrument (vessel sealer) was defective.Instrument malfunctioned during procedure causing a fragment of the instrument to fall into the pt during the procedure.Fragment was retrieved by surgeon; instrument was removed from field and given to appropriate staff.Instrument being sent back to company for analysis per coordinator.

• Brand Name: DA VINCI VESSEL SEALER
• Common Device Name: SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; sunnyvale CA 94086
• MDR Report Key: 7697703
• Report Number: MW5078449
• Device Sequence Number: 1065640
• Product Code: NAY
• UDI-Device Identifier: 00886874112748
• UDI-Public: 00886874112748
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

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: 04/30/2020
• Device Lot Number: M11180426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR