• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MEDTRONIC EEA AUTOSUTURE CIRCULAR STAPLER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN MEDTRONIC EEA AUTOSUTURE CIRCULAR STAPLER Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEEA AUTOSUTURE CIRCULAR STAPLER
Type of DeviceCIRCULAR STAPLER
Manufacturer (Section D)
COVIDIEN MEDTRONIC
minneapolis MN 55432
MDR Report Key7179012
MDR Text Key96990695
Report NumberMW5074498
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2021
Device MODEL NumberEEAXL2535
Device LOT NumberP6F0405KX
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/09/2018 Patient Sequence Number: 1
-
-