MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC EEA 28MM SINGLE USE STAPLER WITH 3.5MM; DISPOSABLE SURGICAL STAPLING DEVICE

Catalog Number EEA2835

Device Problems Air Leak (1008); Failure to Form Staple (2579)

Patient Problem No Information (3190)

Event Date 01/22/2014

Event Type  Injury  

Event Description

Procedure type: colostomy takedown.According to the reporter: during a colostomy reversal, the surgeons were tying their own purse string with a prolene suture.After deciding on a eea2835, they tied the anvil to the proximate end of the colon.The surgeon then inserted the eea stapler through the lumen.The anvil was attached to the stapler.After firing the stapler and removing it from the lumen, the surgeon noticed that there were partially closed staples inside the "donut," as opposed to all being left in the anastomosis.The surgeon then performed a leak test.This was when they noticed that there was a hole in the anastomosis which was obviously leaking air, during the test.The surgeon then used the ethicon eea (exact code not known).The ethicon stapler also failed to perform a full, air-free anastomosis.After the series of these events, the surgeon then performed a hand-sewn anastomosis.The pt also has an ileostomy with plans to re-connect the intestine in the future.The anastomosis was hand-sewn after the covidien and ethicon staplers did not provide a air-tight anastomosis.The hand sewn.

Manufacturer Narrative

(b)(4).

• Brand Name: EEA 28MM SINGLE USE STAPLER WITH 3.5MM
• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC; building 911-67; 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: 3640829
• MDR Text Key: 4354367
• Report Number: 2647580-2014-00079
• 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: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EEA2835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2014
• 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
• Patient Outcome(s): Required Intervention