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

Model Number EEA28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

User facility listed in initial reporter.(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.(b)(4).

Event Description

According to the reporter, during a colon resection, the surgeon used stapler and apparently seemed to work normally, however, there was a small opening in the anastomosis.The opening was sutured closed and no patient issue was reported.Staple line was oversewn where there was a leak.Fired eea to create anastomosis.It seemed to fire fine, there was a hole.It was oversewn to close bowl/anastomosis.Last known patient status was fine.

Manufacturer Narrative

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.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 amended as appropriate.

• Brand Name: EEA 28MM SINGLE-USE STAPLER
• Type of Device: STAPLER, 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 Key: 6041604
• MDR Text Key: 57878251
• Report Number: 2647580-2016-00848
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P3J0620KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention