MAUDE Adverse Event Report: INTUITIVE DAVINCI INTUITIVE ENDOWNIST VESSEL SEALER; SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT

Model Number 502158-03

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663)

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

Event Date 05/23/2017

Event Type  malfunction  

Event Description

Vessel sealer stopped cauterizing mid procedure.No patient harm.

• Brand Name: DAVINCI INTUITIVE ENDOWNIST VESSEL SEALER
• Type of Device: SYSTEM, SURGICAL COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE; 1266 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6646883
• MDR Text Key: 77864521
• Report Number: MW5070448
• Device Sequence Number: 1
• Product Code: NAY
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 502158-03
• Device Catalogue Number: 410322
• Device Lot Number: M11161215
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 39 YR