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

Model Number EEA31

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.

Event Description

According to the reporter, during stapling the anvil remained stuck in the rectum.The physician had to pull in the colon, there was an anal dilatation.The patient had a small tear on the colon.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one device.The visual inspection of the staple guide noted the instrument was fully applied.A microscope examination of the device displayed nicks on the knife blade.Inspection of the anvil cutting ring showed shallow traces of knife impression and the ring was received partially severed.The instrument was applied to the appropriate test media producing acceptable results, despite the noted knife blade damage.The device was subjected to a measured anvil retention test with an acceptable result.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.The information booklet cautions the user to make certain the section of the tissue to be stapled is free from any metal clips or similar structures; otherwise, the knife blade may not cut or the staple line may be incomplete.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.No enhancements or improvements were generated for the reported condition.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EEA 31MM SINGLE-USE STAPLER
• 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: 6118717
• MDR Text Key: 60621088
• Report Number: 2647580-2016-00991
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P5C0728KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention