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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 25MM SINGLE-USE STAPLER STAPLER, SURGICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 25MM SINGLE-USE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number EEA25
Device Problems Failure to Form Staple (2579); Failure to Cut (2587)
Patient Problem No Code Available (3191)
Event Date 11/11/2016
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

During procedure, the reload shot the staples line but the staples didn't make the "b" shape, and the tissue wasn't cut. So they decide to remove the staples line and suture manually. There is no patient harm.

 
Event Description

Additional information provided: the stapler did not make the donut. The stapler partially fired but did not release staples. Staples fell into the patient's cavity and were removed.

 
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Brand NameEEA 25MM 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 Key6186369
MDR Text Key62746365
Report Number2647580-2016-01113
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK111825
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 11/24/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2020
Device MODEL NumberEEA25
Device Catalogue NumberEEA25
Device LOT NumberP5A0193KX
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 Received01/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2015
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: 12/19/2016 Patient Sequence Number: 1
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