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

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 21MM SINGLE USE STAPLER WITH 3.5MM STAPLES STAPLER, SURGICAL

  • 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, FORMERLY USSC PUERTO RICO INC EEA 21MM SINGLE USE STAPLER WITH 3.5MM STAPLES STAPLER, SURGICAL Back to Search Results
Model Number EEA2135
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Tissue Damage (2104); Blood Loss (2597)
Event Date 11/19/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6).

 
Event Description

According to the reporter, the patient had a partial gastrectomy with roux-en-y procedure. A day later the patient had to have a reoperation due to bleeding from the staple line created by the device. The bleeding was noticed post-operatively. Reoperation was performed for the evacuation of the hematoma and placement of the gastric tube. During the reoperation, the bleeding stopped and no additional medical intervention was required. There was no tissue loss, but there was tissue damage around the stomach. The tissue damage was not permanent. There was blood loss of 500cc or more. Initial surgical time was extended by more than 30 minutes.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEEA 21MM SINGLE USE STAPLER WITH 3.5MM STAPLES
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer (Section G)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
MDR Report Key6190223
MDR Text Key62853511
Report Number2647580-2016-01124
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEEA2135
Device Catalogue NumberEEA2135
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/20/2016 Patient Sequence Number: 1
-
-