MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES; STAPLER, SURGICAL

Model Number EEAXL2535

Device Problems Misfire (2532); Failure to Form Staple (2579)

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

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

According to the reporter, during a total gastrectomy the surgeon was not able to get proper anastomosis after firing the stapler; the doughnuts were not properly formed.The device partially fired and there was poor staple formation.To correct the condition, the surgeon used a second stapler to fix the staple line, a little tissue was resected.Surgical time was extended by more than 30 minutes due to this condition.The last known patient status is reported as stable.No reinforcement material was used.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the device had acceptable results.Visual and functional testing of the returned product confirmed the product met specifications that were tested regarding the reported condition.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EEA XL 25MM 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: 6067999
• MDR Text Key: 58813540
• Report Number: 2647580-2016-00893
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: EEAXL2535
• Device Catalogue Number: EEAXL2535
• Device Lot Number: P3K0017KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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): Disability
• Patient Age: 74 YR
• Patient Weight: 67