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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 Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 10/06/2016
Event Type  Injury  
Manufacturer Narrative

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, during a colectomy procedure, they performed the anastomosis but one hour later there was bleeding and the patient had to be re-operated in order to suture the open vessel using a clip. There was less than 500 bleeding. No tissue damaged or loss. The surgeon informs that he has the sensation that the blade does not cut properly. They have discarded the clinical sample so we are going to send a representative unit belonging to the same lot and box.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Per additional information received, according to the reporter, the last known patient status is good. There were no issues with the staple line after the first procedure. There was no leak test performed after the first procedure, but no bleeding was noticed. The bleeding was discovered after a few hours. The blood loss was less than 500cc.

 
Manufacturer Narrative

Ftr# (b)(4). Evaluation summary: post market vigilance (pmv) led an evaluation of one sealed stapler. 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. The file will be closed as fired satisfactorily as the device was found to meet all visual and functional test specifications. 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 06473
2034925267
MDR Report Key6069772
MDR Text Key58915858
Report Number2647580-2016-00900
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeSP
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,Followup
Report Date 10/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2021
Device MODEL NumberEEA28
Device Catalogue NumberEEA28
Device LOT NumberP6C0549KQX
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 Received01/09/2017
Was Device Evaluated By Manufacturer? Yes
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: 11/01/2016 Patient Sequence Number: 1
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