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

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).

• 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: 6038478
• MDR Text Key: 57773713
• Report Number: 2647580-2016-00840
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10884523005530
• UDI-Public: (01)10884523005530(17)210831(10)P6H0272KX
• 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: Nurse
• 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 Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P6H0272KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention