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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 28MM SINGLE-USE STAPLER STAPLER, SURGICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 28MM SINGLE-USE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number EEA28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

User facility listed in initial reporter. (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. (b)(4).

 
Event Description

According to the reporter, during a colon resection, the surgeon used stapler and apparently seemed to work normally, however, there was a small opening in the anastomosis. The opening was sutured closed and no patient issue was reported. Staple line was oversewn where there was a leak. Fired eea to create anastomosis. It seemed to fire fine, there was a hole. It was oversewn to close bowl/anastomosis. Last known patient status was fine.

 
Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one stapler opened by the account. This evaluation was based on a medical and technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device. The visual inspection and functional evaluation of the device had acceptable results. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

 
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Brand NameEEA 28MM 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 Key6041604
MDR Text Key57878251
Report Number2647580-2016-00848
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device MODEL NumberEEA28
Device Catalogue NumberEEA28
Device LOT NumberP3J0620KX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2013
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: 10/19/2016 Patient Sequence Number: 1
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