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

Model Number EEAXL2535

Device Problems Failure To Adhere Or Bond (1031); Fluid/Blood Leak (1250)

Patient Problems Wound Dehiscence (1154); No Code Available (3191)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, the patient developed a post-operative anastomotic dehiscence after a minimally invasive esophagectomy procedure, resulting in an anastomotic leak.The surgeon stated that the staplers performed as expected, with no intra-operative leak observed.An additional endoscopic operation was performed to place a stent at the site of the leak.The current status of the patient is alive / stable.

• Brand Name: EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES
• 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: 6230493
• MDR Text Key: 64082948
• Report Number: 2647580-2017-00020
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEAXL2535
• Device Catalogue Number: EEAXL2535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: STAPLE, IMPLANTABLE
• Patient Outcome(s): Hospitalization; Required Intervention