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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 Problems Difficult to Remove (1528); Failure to Cut (2587); Noise, Audible (3273)
Patient Problem Tissue Damage (2104)
Event Date 10/27/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

According to the reporter, during an esophagoscopy procedure, the surgeon was unable to remove the stapler. The surgeon was using the device to complete anastomosis. The stapler did not click and therefore tore the tissue to remove the stapler. The device did fire, but did not cut the full circle of tissue. The device was not applied over a previous staple line. There was tissue damage due to this issue. To treat the problem, they oversewed. The damage was not permanent.

 
Manufacturer Narrative

(b)(4). Received stapler only, no anvil returned.

 
Manufacturer Narrative

(b)(4). 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. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

 
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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 Key6144505
MDR Text Key61433560
Report Number2647580-2016-01034
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeCA
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 11/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2016
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 NumberEEAXL28
Device Catalogue NumberEEAXL28
Device LOT NumberP6C0288KX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2016
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: 12/05/2016 Patient Sequence Number: 1
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