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U.S. Department of Health and Human Services

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

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA XL 28MM SINGLE-USE STAPLER STAPLER, SURGICAL Back to Search Results
Model Number EEAXL28
Device Problem Failure to Form Staple (2579)
Patient Problem No Code Available (3191)
Event Date 09/21/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). Additional information has been requested but not yet received. A supplemental will be submitted upon receipt of any new information.

 
Event Description

According to the reporter: occurred during a laparoscopic gastrectomy procedure. When the surgeon fired the device, the staples did not form in the 'b' shape. So it failed to make the end-to-end anastomosis. The procedure time was extended by more than thirty minutes.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

(b)(4). Evaluation summary: post market vigilance (pmv) led an evaluation of one eea xl 25mm single-use 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 of the staple guide noted the instrument was fully applied. Since the clinical anvil was not received, a pmv representative anvil was used for all functional testing. A microscope examination of the device displayed nicks on the knife blade. Functionally, the device was reloaded with a full complement of staples and applied to the appropriate test media producing acceptable results. The knife cut the media cleanly and completely and a full complement of staples was deployed and properly formed, despite the noted knife blade damage. Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction. The file will be closed as a misuse of the product. Should new information become available, the file will be re-opened and reassessed at that time. (b)(4). H10. Additional information: g4, g7, h2, h3, h6.

 
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Brand NameEEA XL 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 Key6034153
MDR Text Key57636040
Report Number2647580-2016-00826
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeKS
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,Followup
Report Date 09/23/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2020
Device MODEL NumberEEAXL28
Device Catalogue NumberEEAXL28
Device LOT NumberP5B0512KX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/31/2016
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
Date Device Manufactured02/01/2015
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: 10/17/2016 Patient Sequence Number: 1
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