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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 Insufficient Information (3190)
Patient Problem Obstruction/Occlusion (2422)
Event Date 11/25/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Patient information not provided. Udi not provided. Re-processing information not provided. Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.

 
Event Description

According to the reporter. The patient came a week after the surgery with stenosis. Doctor recommended to develop a colonoscopy, the results showed that the intestinal lumen was obstructed. It was developed a dilatation process with a balloon to solve the obstruction.

 
Event Description

Additional information provided: the date of the original procedure was (b)(6) 2016. The date of the intervention was (b)(6) 2016. No reinforcement material was used. The patient is in good condition.

 
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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, CT 06473
2034925267
MDR Report Key6190274
MDR Text Key62856724
Report Number2647580-2016-01127
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodePM
PMA/PMN NumberK111825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2016
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? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2021
Device MODEL NumberEEA31
Device Catalogue NumberEEA31
Device LOT NumberP6C0008KX
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 Received12/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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