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 Problem Misfire (2532)

Patient Problem No Code Available (3191)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

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Event Description

According to the reporter: during a roux-en-y procedure, the device was used to complete an anastamosis.After firing, one of the donut holes was not complete.It was from the stomach pouch side.The anastamosis was then tested for leaks and a leak was discovered.The anastomosis was over sewn, and tested for leaks again and it was fine.The patient is currently fine.

• 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: 5973952
• MDR Text Key: 55488771
• Report Number: 2647580-2016-00756
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• 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
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention