MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI XI VESSEL SEALER

Catalog Number 480322-07

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  Other  

Event Description

Xi vessel sealer instrument "recognition" issue.System failed to recognize instrument causing another instrument to be used.No patient harm.

• Brand Name: DA VINCI XI VESSEL SEALER
• Type of Device: DA VINCI XI VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7104530
• MDR Text Key: 94518764
• Report Number: MW5073880
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 480322-07
• Device Lot Number: N10110110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1