MAUDE Adverse Event Report: COVIDIEN MEDTRONIC EEA AUTOSUTURE CIRCULAR STAPLER

Model Number EEAXL2535

Device Problems Failure to Cut (2587); Failure to Fire (2610)

Patient Problem Tissue Damage (2104)

Event Date 12/14/2017

Event Type  Injury  

Event Description

Pt was undergoing a robotic gastrectomy procedure.The stapler was docked and fired but there were no staples fired and no cutting of the tissue.On withdrawal of the stapler, the anvil did not undock from the spike.Upon removing the anvil, there was a tear in the esophagus requiring a thoracotomy to repair.

• Brand Name: EEA AUTOSUTURE CIRCULAR STAPLER
• Type of Device: CIRCULAR STAPLER
• Manufacturer (Section D): COVIDIEN MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 7179012
• MDR Text Key: 96990695
• Report Number: MW5074498
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: EEAXL2535
• Device Lot Number: P6F0405KX
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 124