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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 Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

According to the reporter, during a laparoscopic sigmoid procedure, the surgeon resected the colon and determined a 28 would be the best size for the patient. The pa then fired the stapler and noticed the donuts were complete. They did endoscopy to look at the anastomosis and test. Bubbles were observed. There was a diverticulum near the staple line and there were also bubbles coming from the staple line area. The staple line appeared to be intact. The surgeon had to oversew the diverticulum and the staple line. The stapler seemed to act appropriately in all steps of the firing process. Surgery time was delayed by more than 30 minutes. The delay did not affect the patient in any way. The patient status is fine.

 
Manufacturer Narrative

(b)(4). Post market vigilance (pmv) led an evaluation of one device. Visual inspection under the microscope displayed nicks on the knife blade. The stapler was reloaded and applied to test media with acceptable results. The reported condition was confirmed. 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. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. (b)(4).

 
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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, CT 06473
2034925267
MDR Report Key6038478
MDR Text Key57773713
Report Number2647580-2016-00840
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/21/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2021
Device MODEL NumberEEA28
Device Catalogue NumberEEA28
Device LOT NumberP6H0272KX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/26/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2016
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: 10/18/2016 Patient Sequence Number: 1
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