MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA XL 21MM SINGLE USE STAPLER WITH 3.5MM STAPLES; STAPLER, SURGICAL

Model Number EEAXL2135

Device Problem Failure to Form Staple (2579)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

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Event Description

According to the reporter, during a lap gastric bypass involving the stomach, when the stapler was being fired to create the anastomosis a section of the circular staple line did not place staples.This resulted in a hole in the anastomosis.To correct the condition, they transected the original staple line and re-did the entire anastomosis with a new anvil and new stapler.No reinforcement material was used.

• Brand Name: EEA XL 21MM 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
• MDR Report Key: 6087501
• MDR Text Key: 59426522
• Report Number: 2647580-2016-00940
• 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: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: EEAXL2135
• Device Catalogue Number: EEAXL2135
• Device Lot Number: P6D0309KX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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): Required Intervention; Disability