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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES STAPLER, SURGICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES STAPLER, SURGICAL Back to Search Results
Model Number EEAXL2535
Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Misfire (2532)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Date 11/15/2016
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

According to the reporter, during a lap. Total gastrectomy , after inserting the devices into esophagus and jejunum, surgeon could not connect stapler with the anvil. The procedure was converted to an open surgery due to this event. During an open surgery, the surgeon fired the device, but the donut tissue at the oral side was not completed. The surgeon said that there was no difficulty in removal of the device and that the tissue was not thick or thin. The procedure was completed with a competitor's device. Udi number is not available. The status of the patient: no problem. Additional tissue resection was required due to the issue. The patient gender is not available. The patient age is not available. The patient weight is not available.

 
Manufacturer Narrative

(b)(4). Post market vigilance (pmv) led an evaluation of one device the visual inspection of the staple guide noted the instrument was fully applied. The anvil of the instrument was observed to be tilted and separated from the instrument. However, one of the retainer legs of the anvil was observed to be bent. Functionally, a pmv representative anvil was used for firing due to the observed retainer leg damage of the clinical anvil. A microscope examination of the device displayed nicks on the knife blade. The device was applied over the appropriate test media producing acceptable results. The knife cut the test media cleanly and completely, despite the noted knife blade damage. The device was subjected to a measured anvil attachment test with acceptable results. Product analysis suggests the product was used in a surgical procedure. Replication of the observed anvil damage and staple guide damage may occur if the anvil is manipulated with excessive force during the attachment to the instrument, or if the anvil is mishandled during the removal of fitting accessories. Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction. The information booklet cautions the user to make certain the section of the tissue to be stapled is free from any metal clips or similar structures; otherwise, the knife blade may not cut. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident. No enhancements or improvements were generated for the reported condition. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

 
Event Description

According to the reporter,no reinforcement material was used in conjunction with the stapling device. The last known patient status is fine. The anvil was bent. The tissue to be stapled was not free from any metal clips or similar structures. The device was applied over a previous staple line. It was a double stapling with the previous staple line on esophagus.

 
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Brand NameEEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES
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 Key6171462
MDR Text Key62312387
Report Number2647580-2016-01080
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeJA
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 11/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2021
Device MODEL NumberEEAXL2535
Device Catalogue NumberEEAXL2535
Device LOT NumberP6A0484KX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/11/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2016
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: 12/13/2016 Patient Sequence Number: 1
Treatment
STAPLE, IMPLANTABLE, (B)(6) 2016
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