MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA 31MM SINGLE-USE STAPLER; DISPOSABLE SURGICAL STAPLING DEVICE

Model Number EEA31

Device Problems Break (1069); Crack (1135); Difficult to Remove (1528); Noise, Audible (3273)

Patient Problem Failure to Anastomose (1028)

Event Date 11/07/2014

Event Type  Injury  

Event Description

Procedure type: anterior resection.According to the reporter: when the handle was squeezed to fire, a surgeon found that the device was cracked and made strange sounds.The safety release component was broken.It was difficult to remove from the cavity so the surgeon detached the anvil.The stapler was removed and the anvil was retrieved.It was confirmed that no staples were fired on the tissue.The donuts were incomplete.The staple line was over sewn for correction.Another anastomosis was performed with no problems.There was an extension of operating time over 30 minutes.There was intra-operative bleeding.There was unanticipated tissue loss.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: EEA 31MM SINGLE-USE STAPLER
• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• 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: 4301267
• MDR Text Key: 5083765
• Report Number: 2647580-2014-01028
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P4B0536KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR