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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 31MM SINGLE-USE STAPLER STAPLER, SURGICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 31MM SINGLE-USE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number EEA31
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 09/14/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

According to the reporter, after a sigmoid resection there was intraluminal bleeding out of the staple line. Tamponade and anti-hemorrhagic were used to stop the bleeding. No reinforcement material was used.

 
Manufacturer Narrative

(b)(4).

 
Event Description

There were no staple formation or staple line issues. There was low bleeding that was treated with tamponade.

 
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Brand NameEEA 31MM SINGLE-USE STAPLER
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 
MDR Report Key6031584
MDR Text Key57551002
Report Number2647580-2016-00821
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK062850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2021
Device MODEL NumberEEA31
Device Catalogue NumberEEA31
Device LOT NumberP6A0298KX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2016
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: 10/14/2016 Patient Sequence Number: 1
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