MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA XL 28MM SINGLE-USE STAPLER; STAPLER, SURGICAL

Model Number EEAXL28

Device Problems Difficult to Remove (1528); Failure to Cut (2587); Noise, Audible (3273)

Patient Problem Tissue Damage (2104)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during an esophagoscopy procedure, the surgeon was unable to remove the stapler.The surgeon was using the device to complete anastomosis.The stapler did not click and therefore tore the tissue to remove the stapler.The device did fire, but did not cut the full circle of tissue.The device was not applied over a previous staple line.There was tissue damage due to this issue.To treat the problem, they oversewed.The damage was not permanent.

Manufacturer Narrative

(b)(4).Received stapler only, no anvil returned.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one stapler opened by the account.This evaluation was based on a medical and technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The visual inspection and functional evaluation of the device had acceptable results.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EEA XL 28MM 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: 6144505
• MDR Text Key: 61433560
• Report Number: 2647580-2016-01034
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2016

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: 03/31/2021
• Device Model Number: EEAXL28
• Device Catalogue Number: EEAXL28
• Device Lot Number: P6C0288KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2017; 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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): Other; Required Intervention