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

Catalog Number EEAXL28

Device Problem Air Leak (1008)

Patient Problem Failure to Anastomose (1028)

Event Date 08/21/2012

Event Type  malfunction  

Event Description

Procedure: low anterior resection.According to the reporter: radial reload fired on distal transection proximal rectum staple line looked great noticed large dog ear on left side of staple line mated eea28 to proximal rectum and fired well, leak test done with air leak noted.Had to oversew staple line around anastomosis.Had to oversew staple line on anastomosis and suture dog ear on tissue.Sulu egiaradmt no lot given see (b)(4).There was no unanticipated tissue loss.There was no bleeding reported in excess of 250cc.The case was not extended by more than 30 minutes.

Manufacturer Narrative

(b)(4).

• Brand Name: EEA XL 28MM SINGLE-USE STAPLER
• Type of Device: DISPOSABLE STAPLER
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO, INC.; building 911-67; 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: 4041998
• MDR Text Key: 19805490
• Report Number: 2647580-2014-00645
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EEAXL28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2012
• 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