MAUDE Adverse Event Report: INTUITIVE SURGICAL DAVINCI INTUITIVE; ENDO WRIST ONE VESSEL SEALER

Catalog Number 410322

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2018

Event Type  malfunction  

Event Description

Endo wrist one vessel sealer not functioning.

• Brand Name: DAVINCI INTUITIVE
• Type of Device: ENDO WRIST ONE VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA 94086
• MDR Report Key: 7313119
• MDR Text Key: 101601861
• Report Number: MW5075645
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1