MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC EEA XL 28MM SINGLE-USE STAPLER; DISPOSABLE SURGICAL STAPLING DEVICE

Catalog Number EEAXL28

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 02/06/2014

Event Type  Injury  

Event Description

Procedure type: sigmoidectomy.According to the reporter: the device fired properly and tissue donuts were complete (proximal was thin) and then bubbles were detected during the air leak.Because of this, the surgeons felt they needed to divert and create a loop ileostomy.Another operation to take down the ileostomy will be needed.Operating room time was extended more than 30 minutes with no effect on the pt.Pre op diagnosis: diverticulitis, pre-existing conditions: diverticulitis.No reinforcement material was used in conjunction with the stapling device.

Manufacturer Narrative

(b)(4).

• Brand Name: EEA XL 28MM SINGLE-USE STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3649385
• MDR Text Key: 4313546
• Report Number: 2647580-2014-00105
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: EEAXL28
• Device Lot Number: P2F0177H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention